Home GUDID 10885380203169 Aero-Med
Primary DI 10885380203169
Brand Aero-Med
Company AERO-MED, LLC
Model CA57425
Catalog number CA57425
Device description Kit Viral Collection for LOR Diagnostics Only
Published 2026-09-28
Public version status New
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 50885380203167 Package GS1 50 In Commercial Distribution 10885380203169 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 50885380203167 50885380203167 10885380203169 10885380203169
GMDN Terms# Term, Definition table Term Definition General specimen collection kit A collection of devices intended exclusively for professional use 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 laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. 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 10885380193002 Aero-Med AERO-MED, LLC OIB 2026-09-29 10192253057591 Aero-Med AERO-MED, LLC OIB 2026-09-28 10192253063226 Aero-Med AERO-MED, LLC OIB 2026-09-28 10192253063332 Aero-Med AERO-MED, LLC OIB 2026-09-28 10192253066760 Aero-Med AERO-MED, LLC OIB 2026-09-28 10192253067644 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380185045 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380185052 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380187889 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380190261 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380190988 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380195822 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380196812 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380196829 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380200601 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380200823 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380200830 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380200892 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380202841 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206559 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206566 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206573 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206580 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380206597 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380207662 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380208836 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380213939 Aero-Med AERO-MED, LLC OIB 2026-09-28 10885380213908 Aero-Med AERO-MED, LLC OIB 2026-09-25 10885380213922 Aero-Med AERO-MED, LLC OIB 2026-09-25 00810010894687 Aero-Med AERO-MED, LLC OIB 2026-09-24