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Aero-Med

FDA UDI

Class II (US FDA UDI)

by Aero-Med Llc

Identity

Trade Name
Aero-Med FDA UDI
Generic Name
Papanicolaou smear kit FDA UDI
Device Name
ThinPrep Collection Tools; Combo FDA UDI
Model / Reference
BRL205 FDA UDI
Description
ThinPrep Collection Tools; Combo FDA UDI

Identifiers

Catalog Number
BRL205 FDA UDI
Primary DI / UDI-DI
10810010890501 FDA UDI
FDA Product Code
OHL FDA UDI
GMDN Term
Papanicolaou smear kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.4530 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

Yes

FDA UDI

Over-the-Counter

No

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: Papanicolaou smear kit

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

Similar devices

Also classified as Papanicolaou smear kit.

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 57f1eb72-34b3-42dc-a0bf-dc656774e86d 34 fields · synced Jun 8, 2026