FDA.reportPublic FDA data

Aero-Med

Primary DI
50885380141148
Brand
Aero-Med
Company
Aero-Med, Ltd.
Model
CA8475
Catalog number
CA8475
Device description
DNA COLLECTION KIT, PRESCIENT ONLY
Published
2019-04-12
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
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380141148PackageGS150In Commercial Distribution
10885380141140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538014114850885380141148
1088538014114010885380141140

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
false
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#

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
10198956498914CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956599437CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956599574CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956601581CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956370487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956539235CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956560406CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956578586CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956585065CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956587236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956589018CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956589094CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956590045CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956594425CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956595330CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956597495CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956598577CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956599420CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956599567CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956599963CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956599987CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956601086CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956601475CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956601482CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
03661219289043LANDANGERLANDANGERLRP2026-09-27
10198956383043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956535428CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956589193CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956590267CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956590304CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25