Home GUDID 50810010890127 Aero-Med
Primary DI 50810010890127
Brand Aero-Med
Company Aero-Med, Ltd.
Model AMM516
Catalog number AMM516
Device description Urine Foley Catheter Kit
Published 2019-03-27
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 50810010890127 Package GS1 100 In Commercial Distribution 10810010890129 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 50810010890127 50810010890127 10810010890129 10810010890129
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.
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 50192253061039 Aero-Med AERO-MED, LLC OIB 2026-02-20 50192253061091 Aero-Med AERO-MED, LLC OIB 2026-02-20 50192253061107 Aero-Med AERO-MED, LLC OIB 2026-02-20 50192253061473 Aero-Med AERO-MED, LLC OIB 2026-02-20 50192253061480 Aero-Med AERO-MED, LLC OIB 2026-02-20 50192253061503 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380176119 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380185036 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380185067 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380185166 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380185180 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380186521 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380186569 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380186590 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380186644 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380186668 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380186675 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380187900 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380188525 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380188662 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380188754 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380188761 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380188792 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380189157 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380189393 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380189409 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380189447 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380189454 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380189898 Aero-Med AERO-MED, LLC OIB 2026-02-20 50885380190979 Aero-Med AERO-MED, LLC OIB 2026-02-20