FDA.report

Aero-Med

Primary DI
50810010894897
Company
AERO-MED, LLC
Model
QUE3525
Catalog number
QUE3525
Device description
Blood Culture Kit-4pk
Published
2025-09-11
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

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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
50810010894897PackageGS110In Commercial Distribution
00810010894892PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
50810010894897PackageGS110CASE00810010894892In Commercial Distribution
00810010894892PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NNKContainer, Specimen Mailer And Storage, Non-Sterile1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
General specimen container IVD, additive/mediumA 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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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
50192253061503Aero-MedCA42200CA422002026-02-20
50885380176119Aero-MedCA28550CA285502026-02-20
50885380185036Aero-MedCA37825CA378252026-02-20
50885380185067Aero-MedCA37625CA376252026-02-20
50885380185166Aero-MedCA37275CA372752026-02-20

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