Home GUDID 10885380209222 Aero-Med
Primary DI 10885380209222
Brand Aero-Med
Company AERO-MED, LLC
Model AMM17775A
Catalog number AMM17775A
Device description Clean Catch Urine Kit
Published 2025-08-26
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 OIB Blood and urine collection kit (excludes HIV testing)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OIB Blood And Urine Collection Kit (Excludes Hiv Testing) Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50885380209220 Package GS1 50 In Commercial Distribution 10885380209222 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 50885380209220 50885380209220 10885380209222 10885380209222
GMDN Terms# Term, Definition table Term Definition General specimen container IVD, additive/medium A covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 194550042 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true 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 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 10885380210891 Aero-Med AERO-MED, LLC OIB 2026-06-10 10885380213465 Aero-Med AERO-MED, LLC OIB 2026-06-10 00810057230448 SNT Biotech SARIS AND THINGS, INC. OIB 2026-06-04 10885380212017 Aero-Med AERO-MED, LLC OIB 2026-06-04 10885380212024 Aero-Med AERO-MED, LLC OIB 2026-06-04 10885380211768 Aero-Med AERO-MED, LLC OIB 2026-05-06 10192253071504 Aero-Med AERO-MED, LLC OIB 2026-04-16 10192253061031 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061093 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061109 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061475 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061482 Aero-Med AERO-MED, LLC OIB 2026-02-20 10192253061505 Aero-Med AERO-MED, LLC OIB 2026-02-20 10885380211188 Aero-Med AERO-MED, LLC OIB 2026-02-13 10885380210921 Aero-Med AERO-MED, LLC OIB 2026-01-20 10885380210938 Aero-Med AERO-MED, LLC OIB 2026-01-20 10885380210877 Aero-Med AERO-MED, LLC OIB 2025-12-26 10885380208935 Aero-Med AERO-MED, LLC OIB 2025-11-04 10885380208928 Aero-Med AERO-MED, LLC OIB 2025-08-21 10885380208447 Aero-Med AERO-MED, LLC OIB 2025-06-10 10885380208461 Aero-Med AERO-MED, LLC OIB 2025-06-10 10194717120087 Regard™ ROI CPS, LLC OIB 2024-10-02 10885380203657 Aero-Med AERO-MED, LLC OIB 2024-08-01 10885380203664 Aero-Med AERO-MED, LLC OIB 2024-08-01 10194717119739 Regard™ ROI CPS, LLC OIB 2024-07-19 10194717119449 Regard™ ROI CPS, LLC OIB 2024-05-21 10885380199165 Aero-Med AERO-MED, LLC OIB 2024-01-31 10885380199172 Aero-Med AERO-MED, LLC OIB 2024-01-31 10885380199035 Aero-Med AERO-MED, LLC OIB 2024-01-10 10885380199042 Aero-Med AERO-MED, LLC OIB 2024-01-10