Home GUDID 20680651487654 PUREZERO* MARIN* XTRA*
Primary DI 20680651487654
Brand PUREZERO* MARIN* XTRA*
Company O&M HALYARD, INC.
Model 48765
Catalog number 48765
Device description HYH,LFS,PUREZERO GLOVE,BU,XL
Published 2022-06-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name LZA Polymer patient examination glove LZC Patient examination glove, specialty OPJ Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs QDO Fentanyl and other opioid protection glove
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LZA Polymer Patient Examination Glove General Hospital 1 LZC Medical Glove, Specialty General Hospital 1 OPJ Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs General Hospital 1 QDO Fentanyl And Other Opioid Protection Glove General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30680651487651 Package GS1 10 In Commercial Distribution 20680651487654 Primary GS1 0 90680651487653 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30680651487651 30680651487651 20680651487654 20680651487654 90680651487653 90680651487653
GMDN Terms# Term, Definition table Term Definition Nitrile examination/treatment glove, non-powdered, non-antimicrobial A device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.
Regulatory Flags# DUNS number 081057389 Device count 50 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00199972000641 Curaplex BOUND TREE MEDICAL, LLC LZA 2026-10-15 00199972000641 Curaplex BOUND TREE MEDICAL, LLC QDO 2026-10-15 00199972000641 Curaplex BOUND TREE MEDICAL, LLC LZC 2026-10-15 00199972000672 Curaplex BOUND TREE MEDICAL, LLC QDO 2026-10-15 00199972000672 Curaplex BOUND TREE MEDICAL, LLC LZC 2026-10-15 00199972000672 Curaplex BOUND TREE MEDICAL, LLC LZA 2026-10-15 00199972000702 Curaplex BOUND TREE MEDICAL, LLC QDO 2026-10-15 00199972000702 Curaplex BOUND TREE MEDICAL, LLC LZA 2026-10-15 00199972000702 Curaplex BOUND TREE MEDICAL, LLC LZC 2026-10-15 00199972000733 Curaplex BOUND TREE MEDICAL, LLC QDO 2026-10-15 00199972000733 Curaplex BOUND TREE MEDICAL, LLC LZA 2026-10-15 00199972000733 Curaplex BOUND TREE MEDICAL, LLC LZC 2026-10-15 00199972000764 Curaplex BOUND TREE MEDICAL, LLC QDO 2026-10-15 00199972000764 Curaplex BOUND TREE MEDICAL, LLC LZA 2026-10-15 00199972000764 Curaplex BOUND TREE MEDICAL, LLC LZC 2026-10-15 00850069531010 Elevate Blu Maxter Healthcare Incorporated QDO 2026-10-15 00850069531010 Elevate Blu Maxter Healthcare Incorporated LZC 2026-10-15 00850069531010 Elevate Blu Maxter Healthcare Incorporated LZA 2026-10-15 00850069531010 Elevate Blu Maxter Healthcare Incorporated OPJ 2026-10-15 00850069531027 Elevate Blu Maxter Healthcare Incorporated QDO 2026-10-15 00850069531027 Elevate Blu Maxter Healthcare Incorporated OPJ 2026-10-15 00850069531027 Elevate Blu Maxter Healthcare Incorporated LZA 2026-10-15 00850069531027 Elevate Blu Maxter Healthcare Incorporated LZC 2026-10-15 00850069531034 Elevate Blu Maxter Healthcare Incorporated QDO 2026-10-15 00850069531034 Elevate Blu Maxter Healthcare Incorporated OPJ 2026-10-15 00850069531034 Elevate Blu Maxter Healthcare Incorporated LZC 2026-10-15 00850069531034 Elevate Blu Maxter Healthcare Incorporated LZA 2026-10-15 00850069531041 Elevate Blu Maxter Healthcare Incorporated QDO 2026-10-15 00850069531041 Elevate Blu Maxter Healthcare Incorporated OPJ 2026-10-15 00850069531041 Elevate Blu Maxter Healthcare Incorporated LZA 2026-10-15
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