FDA.reportPublic FDA data

Aero-Med

Primary DI
50885380121614
Brand
Aero-Med
Company
AERO-MED, LLC
Model
CA2200
Catalog number
CA2200
Device description
FLU SPEC COLLECTION KIT, CONCORD HO
Published
2019-04-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
50885380121614PrimaryGS10
10885380121616Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538012161450885380121614
1088538012161610885380121616

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
50
Premarket exempt
true
Kit
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213953Aero-MedCA65375CA653752026-10-06
10885380195839Aero-MedCA2300BCA2300B2023-06-14
10885380193002Aero-MedCA30725CA307252026-09-29
10192253061093Aero-MedCA39450CA394502026-02-20
10885380182808Aero-MedCA29150CA291502020-11-02
10192253057591Aero-MedCA40000CA400002026-09-28
10192253063226Aero-MedCA42700ACA42700A2026-09-28
10192253063332Aero-MedCA44925CA449252026-09-28
10192253066760Aero-MedCA39525ACA39525A2026-09-28
10192253067644Aero-MedCA61050CA610502026-09-28
10885380185045Aero-MedCA37600CA376002026-09-28
10885380185052Aero-MedCA37575CA375752026-09-28
10885380187889Aero-MedCA39325CA393252026-09-28
10885380190261Aero-MedCA41500CA415002026-09-28
10885380190988Aero-MedCA42025CA420252026-09-28
10885380195822Aero-MedCA46425CA464252026-09-28
10885380196812Aero-MedCA50450CA504502026-09-28
10885380196829Aero-MedCA50600CA506002026-09-28
10885380200601Aero-MedCA56375CA563752026-09-28
10885380200823Aero-MedCA56075CA560752026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810017915309SABER-XA, Screw CaddyELEVATION SPINE, INC.LRP2026-10-06
00810017915316SABER-XA, Cage & Plate Caddy, 34Wx26DELEVATION SPINE, INC.LRP2026-10-06
00810017915323SABER-XA, Cage & Plate Caddy, 37Wx28DELEVATION SPINE, INC.LRP2026-10-06
00810017915330SABER-XA, Cage & Plate Caddy, 40Wx30DELEVATION SPINE, INC.LRP2026-10-06
00810017915347SABER-XA, Spike CaddyELEVATION SPINE, INC.LRP2026-10-06
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10198956552340CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
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10198956604605CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956604698CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956605756CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
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10198956606302CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956608917CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
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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