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
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
G586961003A0Novo SurgicalNOVO SURGICAL, INC.LRP2024-02-22
G429MSS820160Stainless steel bowl small 6CMMEED SKILL SURGICALLRP2023-03-03
G141588222990Carnegie Surgical LLCCarnegie Surgical LLCLRP2023-02-13
07899798205796QuinelatoSchobell Industrial LtdaLRP2022-12-20
10080196055159MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196818778MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196848041MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196996681MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10190001934897MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190021MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190076MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190137MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190304MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190342MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190380MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190489MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190564MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191066MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191073MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191080MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191097MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191103MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191141MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191189MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191240MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190199MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190205MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190212MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190250MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16