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Aero-Med BRL165

by Aero-Med LLC

Aero-Med BRL165 is a papanicolaou smear kit (FDA Class II; FDA product code OHL, Pap smear kit) made by Aero-Med LLC, listed in FDA GUDID since 16 Jan 2019 (UDI-DI 10810010890471), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810010890471 UDI-DI Date16 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Aero-Med
Generic name
Papanicolaou smear kit
Model / Ref / Catalog
BRL165
Primary DI / UDI-DI
10810010890471
FDA product code
OHL
GMDN term
Papanicolaou smear kit
Device class
Class II
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution

Related devices

Category: Papanicolaou smear kit

Other devices from Aero-Med LLC

See all devices from Aero-Med LLC →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)