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Tempo 8010

by Hemasource

Tempo 8010 is a device classified as Unclassified made by Hemasource, listed in FDA GUDID since 8 Dec 2022 (UDI-DI 00891153001187), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00891153001187 UDI-DI Date8 Dec 2022ListedStatusListed 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  • Withdrawn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
Tempo
Generic name
Antiseptic skin towelette
Model / reference
8010
Primary DI / UDI-DI
00891153001187
FDA product code
LKB
GMDN term
Antiseptic skin towelette
Device class
U
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Similar devices

Other devices filed under FDA product code LKB (Pad, Alcohol, Device Disinfectant).

Other devices from Hemasource

See all devices from Hemasource →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)