Home GUDID 10885380199165 Aero-Med
Primary DI 10885380199165
Brand Aero-Med
Company AERO-MED, LLC
Model CA52075
Catalog number CA52075
Device description Kit Urine Collection for Behavioral Health for UNC Health Only
Published 2024-01-31
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 50885380199163 Package GS1 50 In Commercial Distribution 10885380199165 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 50885380199163 50885380199163 10885380199165 10885380199165
GMDN Terms# Term, Definition table Term Definition Urine specimen collection kit IVD A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. 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 false 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 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 10885380209222 Aero-Med AERO-MED, LLC OIB 2025-08-26 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 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