FDA.reportPublic FDA data

Aero-Med

Primary DI
00810010892409
Brand
Aero-Med
Company
AERO-MED, LLC
Model
BHD400A
Catalog number
BHD400A
Device description
Buccal Swab Kit
Published
2019-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00810010892409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810010892409008100108924098100108924090810010892409

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)200-6313xxx@xxx.xxx

Regulatory Flags#

DUNS number
194550042
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10885380200830Aero-MedCA56100CA561002026-09-28

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