FDA.reportPublic FDA data

Aero-Med

Primary DI
50810010893098
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
AMM5975
Catalog number
AMM5975
Device description
Oral Fluid Kit
Published
2021-03-08
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
CodeName
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810010893098PackageGS11In Commercial Distribution
00810010893093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089309850810010893098
00810010893093008100108930938100108930930810010893093

GMDN Terms#

Term, Definition table
TermDefinition
Oral specimen collection kit, no additiveA collection of non-sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the mouth, for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture]. It includes a specimen collection tool(s) [e.g., swab, brush, spatula], sometimes sterile, and a covered empty plastic receptacle. This is a single-use device.

Sterilization Methods#

Method table
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50192253068748Aero-MedCA38075BCA38075B2025-05-01
50885380208308Aero-MedCA1500ACA1500A2025-04-18
50885380183667Aero-MedCA18750ACA18750A2025-04-15
50885380207721Aero-MedCA18725BCA18725B2025-04-15
50810010894729Aero-MedQUE3325QUE33252025-04-10
50885380207707Aero-MedCA38075BCA38075B2025-04-08
50885380207714Aero-MedCA38100BCA38100B2025-04-08
50885380208063Aero-MedCA14800BCA14800B2025-04-07
50885380198715Aero-MedCA54550CA545502024-01-08
50885380207745Aero-MedCA61875CA618752025-04-02
50885380198708Aero-MedCA32250BCA32250B2024-01-08
50885380207455Aero-MedCA61175CA611752025-03-20
50885380207677Aero-MedCA61900CA619002025-03-19
50810010894774Aero-MedAMM19300AMM193002025-03-06
50885380207363Aero-MedCA59025CA590252025-03-03
50885380207448Aero-MedCA59000CA590002025-03-03
50810010894736Aero-MedAMM18850AMM188502025-02-11
50810010894743Aero-MedAMM18875AMM188752025-02-11
50885380205536Aero-MedCA60225CA602252024-10-07
50885380206823Aero-MedCA60675CA606752025-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLS1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, SterileCorramedical Inc.KDT2026-04-07
10809160466940Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
04066916018412urine cup 76x 60Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-14
10198459217074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDT2024-12-22
30193489107337MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
30193489107344MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
18053326004534BC+™ COPAN ITALIA SPAKDT2022-12-07
38053326010966UriFreeCOPAN ITALIA SPAKDT2022-12-07
00613647005958FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDT2022-12-07
14039943000016CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000023CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000030CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000047CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000054CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000061CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000085CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000092CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000108CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000115CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000122CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000139CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000146CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000153CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000160CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000177CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000184CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000191CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000207CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000214CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000221CRYO.SGreiner Bio - One GmbHKDT2022-12-06