Home GUDID 00860006476038 Shur-Clens
Primary DI 00860006476038
Brand Shur-Clens
Company Asept Pak, Inc.
Model 980093
Device description Case of 24 Containers of Sterile Sodium Chloride 0.9%, USP in 120 mL BFS Container.
Published 2025-04-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FQH Lavage, Jet
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FQH Lavage, Jet General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10860006476035 Primary GS1 0 00860006476038 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10860006476035 10860006476035 00860006476038 00860006476038 860006476038 0860006476038
GMDN Terms# Term, Definition table Term Definition Pressure-regulated wound irrigation solution applicator, manual A hand-held manual device in the form of a compressible bottle with a specialized nozzle, intended to be used to apply a pressure-regulated jet stream of non-medicated topical solution (e.g., sterile water, saline) to mechanically irrigate, clean/moisten, and decontaminate a wound. This is a single-use device.
Regulatory Flags# DUNS number 005245137 Device count 24 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 05051471221512 De Soutter Medical DE SOUTTER MEDICAL LIMITED FQH 2026-05-27 B674PL30010 Perilav Stiehl Tech, LLC FQH 2026-05-13 B674T93LF10 Perilav Stiehl Tech, LLC FQH 2026-05-13 07640407460811 debritom+ Medaxis AG FQH 2026-04-17 07649996166302 debritom+ Medaxis AG FQH 2026-04-17 07649996166043 debritom+ Medaxis AG FQH 2026-04-08 04050147023826 Erbe Erbe Elektromedizin GmbH FQH 2026-04-01 00382909101201 Surgiphor CAREFUSION 2200, INC FQH 2026-03-05 00075450844337 Hy-Vee Saline Wound Wash HY-VEE, INC. FQH 2026-02-19 00850073677032 Shur-Clens Asept Pak, Inc. FQH 2026-02-17 00850073677056 Skin-Clens Asept Pak, Inc. FQH 2026-02-17 04050147022959 Erbe Erbe Elektromedizin GmbH FQH 2025-10-01 04050147022942 Erbe Erbe Elektromedizin GmbH FQH 2025-09-30 10850073677008 Shur-Clens Asept Pak, Inc. FQH 2025-04-30 10860006476035 Shur-Clens Asept Pak, Inc. FQH 2025-04-23 10850073677015 Shur-Clens Asept Pak, Inc. FQH 2025-04-16 10860006476028 Shur-Clens Asept Pak, Inc. FQH 2025-04-16 10842351180027 Irrisept Accessory Kit IRRIMAX CORPORATION FQH 2024-07-22 10842351120047 Irrisept Antimicrobial Wound Lavage IRRIMAX CORPORATION FQH 2024-07-16 10842351180010 Irrisept Wound Solution Kit IRRIMAX CORPORATION FQH 2024-07-01 03600040955086 Elefant Coloplast A/S FQH 2024-04-05 03600040955116 Elefant Coloplast A/S FQH 2024-04-05 03600040970614 Elefant Coloplast A/S FQH 2024-04-05 03600040970645 Elefant Coloplast A/S FQH 2024-04-05 03600040970676 Elefant Coloplast A/S FQH 2024-04-05 03600040970737 Elefant Coloplast A/S FQH 2024-04-05 03600040970768 Elefant Coloplast A/S FQH 2024-04-05 03600040970799 Elefant Coloplast A/S FQH 2024-04-05 00034197018470 Premier Solution Saline Wound Wash Premier Brands of America Inc. FQH 2024-03-12 00032251985164 Family Wellness Saline Wound Wash Family Dollar Stores FQH 2024-03-10