General Hospital

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Code	Device name	Class	21 CFR	510(k) (3y)
OIG	Powder-Free Guayle Rubber Examination Glove	Class 1	21 CFR 880.6250	1
OJA	Intravenous Extension Tubing Set	Class 2	21 CFR 880.5440	1
OKC	Implanted Subcutaneous Securement Catheter	Class 2	21 CFR 880.5970	5
OKE	Port Introducer Kit	Class 2	21 CFR 880.5965
OKL	Intravascular Administration Set, Automated Air Removal System	Class 2	21 CFR 880.5445	2
OMF	Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory Fo	Class 2	21 CFR 880.5970	2
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer S	Class 2	21 CFR 880.5440	41
ONK	Oral Lubricant	Class 1	21 CFR 880.6375	1
ONM	Radiant Infant Warmer Cabinet	Class 2	21 CFR 880.5130
OPC	Powder-Free Polychloroprene Patient Examination Glove	Class 1	21 CFR 880.6250	1
OPH	Radiation Attenuating Medical Glove	Class 1	21 CFR 880.6250
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With C	Class 1	21 CFR 880.6250
OPP	Pump, Infusion, Insulin Bolus	Class 2	21 CFR 880.5725	7
ORW	N95 Respirator With Antimicrobial/Antiviral Agent For Use By The Gener	Class 2	21 CFR 880.6260	1
OSI	Bariatric Bed	Class 2	21 CFR 880.5100
OSZ	Antimicrobial Keyboard	Class 2	21 CFR 880.6600	1
OUG	Medical Device Data System	Class 1	21 CFR 880.6310	1
OUW	Infant Positioner, Rx, Use In Highly Monitored Setting	Class 1	21 CFR 880.5680	1
OVY	Liquid Chemical Processing System	Class 2	21 CFR 880.6887	4
OWL	Peripheral Catheter Insertion Kit	Class 2	21 CFR 880.5200
OWP	Biological Sterilization Process Indicator With Recombinant-Dna Plasmi	Class 2	21 CFR 880.2805	5
OXQ	Dressing Change Tray	Class 1	21 CFR 880.5075
OYS	Patient Bed With Canopy/Restraints	Class 1	21 CFR 880.6760	3
OZK	Thermometer, Exhaled Breath	Class 2	21 CFR 880.2910
OZW	Ingestible Event Marker	Class 2	21 CFR 880.6305	8
PAD	Chest Drainage Kit	Class 2	21 CFR 880.6740
PBZ	Image Processing Device For Estimation Of External Blood Loss	Class 2	21 CFR 880.2750	6
PDH	Blanket, Neonatal Phototherapy	Class 2	21 CFR 880.5700	2
PEC	Sterilizer Automated Loading System	Class 2	21 CFR 880.6880	1
PEF	Heparin Flush In 0.45% Sodium Chloride	Class 2	21 CFR 880.5200
PEQ	Accessories To Examination Light	Class 1	21 CFR 880.6320	1
PEZ	Central Venous Catheter Dressing Change Kit	Class 2	21 CFR 880.5200
PHC	Infusion Safety Management Software	Class 2	21 CFR 880.5725	10
PJJ	Two Or More Sterilant Sterilizer	Class 2	21 CFR 880.6860	6
PJO	Fall Prevention Alarm/Sensor Combination Attached Or Unattached	Class 1	21 CFR 880.2400
PJP	Fall Prevention Alarm/Sensor Attached Only	Class 1	21 CFR 880.2400
PKP	Immunoglobulin G (Igg) Infusion System	Class 2	21 CFR 880.5725	7
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	Class 2	21 CFR 880.5725	5
PND	Midline Catheter	Class 2	21 CFR 880.5200	13
POQ	Blood Transfusion Kit	Class 2	21 CFR 880.5440
POR	Parenteral Administration Kit	Class 2	21 CFR 880.5440
PQH	Iodinated Contrast Media Transfer Tubing Set	Class 2	21 CFR 880.5440	6
PQX	Epinephrine Syringe	Class 2	21 CFR 880.5860	2
PRN	Pediatric Position Holder	Class 1	21 CFR 880.5680
PTD	Subcutaneous Implanted Apheresis Port	Class 2	21 CFR 880.5965	3
PTI	Non-Coring (Huber) Needle	Class 2	21 CFR 880.5570	13
PUK	Administration Set Securement Device	Class 1	21 CFR 880.5210
PUN	Lice Removal Kit Containing A Solution	Class 1	21 CFR 880.5960
PUR	Vacuum Syringe	Class 2	21 CFR 880.5860	2
PVZ	Non-Stainless Steel Needle	Class 2	21 CFR 880.5570	1
PWH	Administrations Sets With Neuraxial Connectors	Class 2	21 CFR 880.5440	4
PWM	Admission Kit (Patient Utensil)	Class 1	21 CFR 880.6730
PWN	Baby Care Kit	Class 2	21 CFR 880.5700
PWO	Blood Administration Kit	Class 2	21 CFR 880.5440
PWP	Blood Borne Pathogen Response Kit	Class 1	21 CFR 880.6250
PWQ	Buret Administration Intravenous Kit	Class 2	21 CFR 880.5440
PWR	Catheter Repair Kit	Class 2	21 CFR 880.5970
PWS	Chemotherapy Administration Kit	Class 1	21 CFR 880.6250
PWT	Chemotherapy Spill Clean-Up Kit	Class 1	21 CFR 880.6250
PWU	Clean-Up Kit	Class 1	21 CFR 880.6890
PWV	Delivery Room Apparel Kit	Class 1	21 CFR 880.6250
PWW	Fever Monitoring Kit	Class 2	21 CFR 880.2910
PWX	Insect Sting Emergency Kit	Class 1	21 CFR 880.5740
PWY	Lumbar Puncture Tray (Adult & Pediatric)	Class 2	21 CFR 880.5570
PWZ	Mid-Stream Collection Kit	Class 1	21 CFR 880.6730
PXA	Oral Administration Set	Class 1	21 CFR 880.6430
PXB	Percutaneous Introducer Kit	Class 2	21 CFR 880.5570
PXC	Personal Protection Kit	Class 1	21 CFR 880.6250
PXD	Prep Kit	Class 1	21 CFR 880.6250
PXF	Sitz Bath Kit	Class 1	21 CFR 880.6730
PXG	Spill Kit	Class 1	21 CFR 880.6890
PXH	Thermometer Kit	Class 2	21 CFR 880.2910
PXI	Thoracentesis Tray	Class 2	21 CFR 880.5570
PXJ	Umbilical Catheter Insertion Tray	Class 2	21 CFR 880.5200
PXK	Vascular Access Port Kit	Class 2	21 CFR 880.5965
PXL	Venipuncture Kit	Class 2	21 CFR 880.5570
PXM	Vomitus Clean-Up Kit	Class 1	21 CFR 880.6890
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	Class 1	21 CFR 880.5240	1
PYQ	Rfid Chip For Dental Appliance	Class 2	21 CFR 880.6300	1
PYR	Neuraxial Administration Set - Intrathecal Delivery	Class 2	21 CFR 880.5440
PZW	Catheter Access Cover, Tamper-Resistant	Class 2	21 CFR 880.5970	2
QBL	Piston Syringe Lever	Class 2	21 CFR 880.5860	3
QBP	Cap, Device Disinfectant	Class 2	21 CFR 880.5440	22
QDM	Midazolam Syringe	Class 2	21 CFR 880.5860
QDO	Fentanyl And Other Opioid Protection Glove	Class 1	21 CFR 880.6250
QEH	Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or	Class 2	21 CFR 880.5860	5
QFB	Isocapnic Ventilation Device	Class 2	21 CFR 868.5480	1
QJT	Rigid Sterilization Container With Software	Class 2	21 CFR 880.6855	1
QJY	Infusion Pump, Drug Specific, Pharmacy-Filled	Class 2	21 CFR 880.5725	4
QKM	A Chemical Vapor Sterilization Multivariable Chemical Indicator	Class 2	21 CFR 880.2800	5
QLF	On-Body Injector	Class 2	21 CFR 880.5860
QLY	Ophthalmic Syringe	Class 2	21 CFR 880.5860	7
QMT	Prep Kit Vaccine Injection	Class 2	21 CFR 880.5570
QNQ	Low Dead Space Piston Syringe	Class 2	21 CFR 880.5860	12
QNS	Low Dead Space Needle, Single Lumen, Hypodermic	Class 2	21 CFR 880.5570	3
QOG	Injection Data Capture Device	Class 2	21 CFR 880.5860	7
QOI	Intravenous Catheter Force-Activated Separation Device.	Class 2	21 CFR 880.5220	8
QQS	Stapler, Skin	Class 1	21 CFR 878.4740
QTG	Infant Supine Sleep System	Class 2	21 CFR 880.5690	1
QTI	Saline Vascular Access Flush With Integrated Alcohol Disinfectant Devi	Class 2	21 CFR 880.5200	1
QTV	Mattress And Bed Deck Cover (Medical Purposes)	Class 1	21 CFR 880.6190	1
QVB	Biological Sterilization Indicator With Indirect Growth Detection	Class 2	21 CFR 880.2806	3
QVY	Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinen	Class 2	21 CFR 880.5151	1
QWS	Foam Or Gel Chemical Sterilant/High Level Disinfectant	Class 2	21 CFR 880.6886	2
QWX	Active Noise Attenuation System For Infant Incubators	Class 2	21 CFR 880.5405	1
QXC	Diabetes Digital Therapeutic Device	Class 2	21 CFR 880.5735	1
QXJ	Whole Room Microbial Reduction Device	Class 2	21 CFR 880.6510	2
QXQ	Respiratory Accessory Microbial Reduction Device.	Class 2	21 CFR 880.6993	3
QYM	Ophthalmic Needle	Class 2	21 CFR 880.5570	2
QZA	Body Temperature Sensing Software	Class 2	21 CFR 880.2915	2
SAK	Software Device To Aid In The Prediction Or Diagnosis Of Sepsis	Class 2	21 CFR 880.6316	2
SBE	Digital Physical/Chemical Sterilization Process Sensor	Class 2	21 CFR 880.2801	1
SBO	Bed-Patient Activity Monitoring System	Class 1	21 CFR 880.2400	1
SCL	Allergen And Vaccine Delivery Needles	Class 2	21 CFR 880.5570	25
SCS	Ultraviolet Radiation Disinfection Chamber Device	Class 2	21 CFR 880.6511	2
SDC	Qualitative Cleaning Process Protein Indicator	Class 2	21 CFR 880.6930	1
SDV	Clinical Electronic Thermometer	Class 2	21 CFR 880.2910
SDW	Stationary Infrared Thermometer	Class 2	21 CFR 880.2910
SEF	Central Venous Catheter With Manual Insertion System	Class 2	21 CFR 880.5200	1
SEW	Automated Endoscope Channel Cleaner	Class 2	21 CFR 880.6994	2
SGX	Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated	Class 2	21 CFR 880.6512	1
SHM	Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe	Class 2	21 CFR 880.6891	1