Aero-Med

Primary DI
50192253061503
Brand
Aero-Med
Company
AERO-MED, LLC
Model
CA42200
Catalog number
CA42200
Device description
Kit Dry Viral Transport Specimen Collection, St. John's - Ascension Health Alliance only
Published
2026-02-20
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

Related Records

Product Codes

CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications

CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253061503PackageGS150In Commercial Distribution
10192253061505PrimaryGS10

GMDN Terms

TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic 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 in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Sterilization Methods

Method

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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50885380211216Aero-MedCA7225ACA7225A2026-03-20
50885380211223Aero-MedLAB422520OCLAB422520OC2026-03-20
50810010894880Aero-MedAMM21200AMM212002026-03-17
50810010894927Aero-MedAMM21225AMM212252026-03-17
50810010894934Aero-MedAMM21250AMM212502026-03-17
50810010894941Aero-MedAMM21275AMM212752026-03-17
50810010894958Aero-MedAMM3675FAMM3675F2026-03-17
00810010894960Aero-MedAMM20800AMM208002026-03-17
00810010894977Aero-MedAMM20825AMM208252026-03-17
00810010894984Aero-MedAMM20850AMM208502026-03-17
50192253061039Aero-MedCA27275CA272752026-02-20
50192253061091Aero-MedCA39450CA394502026-02-20
50192253061107Aero-MedCA39075CA390752026-02-20
50192253061473Aero-MedCA39100CA391002026-02-20
50192253061480Aero-MedCA41425CA414252026-02-20
50885380176119Aero-MedCA28550CA285502026-02-20
50885380185036Aero-MedCA37825CA378252026-02-20
50885380185067Aero-MedCA37625CA376252026-02-20
50885380185166Aero-MedCA37275CA372752026-02-20
50885380185180Aero-MedCA37800CA378002026-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50192253061039Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061091Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061107Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061473Aero-MedAERO-MED, LLCOIB2026-02-20
50192253061480Aero-MedAERO-MED, LLCOIB2026-02-20
50885380176119Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185036Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185067Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185166Aero-MedAERO-MED, LLCOIB2026-02-20
50885380185180Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186521Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186569Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186590Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186644Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186668Aero-MedAERO-MED, LLCOIB2026-02-20
50885380186675Aero-MedAERO-MED, LLCOIB2026-02-20
50885380187900Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188525Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188662Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188754Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188761Aero-MedAERO-MED, LLCOIB2026-02-20
50885380188792Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189157Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189393Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189409Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189447Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189454Aero-MedAERO-MED, LLCOIB2026-02-20
50885380189898Aero-MedAERO-MED, LLCOIB2026-02-20
50885380190979Aero-MedAERO-MED, LLCOIB2026-02-20
50885380192850Aero-MedAERO-MED, LLCOIB2026-02-20