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Aero-Med

FDA UDI

Class I (US FDA UDI)

by Aero-Med Llc

Identity

Trade Name
Aero-Med FDA UDI
Generic Name
Saliva/oral specimen collection kit, no additive FDA UDI
Device Name
Buccal Swab Kit FDA UDI
Model / Reference
BHD400 FDA UDI
Description
Buccal Swab Kit FDA UDI

Identifiers

Catalog Number
BHD400 FDA UDI
Primary DI / UDI-DI
10810010890273 FDA UDI
FDA Product Code
LRP FDA UDI
GMDN Term
Saliva/oral specimen collection kit, no additive FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Saliva/oral specimen collection kit, no additive

Aero-Med by Aero-Med Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Saliva/oral specimen collection kit, no additive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aero-Med Llc

Sources (1)

  • FDA UDI 76644add-2243-4dd3-ab2b-e51fd0f7654a 34 fields · synced May 30, 2026