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ProFusion G34864

by Cook Incorporated

ProFusion G34864 (TIN-21-7.5) is a Class I device made by Cook Incorporated, listed in FDA GUDID since 2 Oct 2020 (UDI-DI 00827002348646), 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 Number00827002348646 UDI-DI Date2 Oct 2020ListedStatusListed 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  • Withdrawn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
ProFusion
Generic name
Subcutaneous infusion/injection port needle
Model / Ref / Catalog
G34864, TIN-21-7.5
Primary DI / UDI-DI
00827002348646
FDA product code
GAA
GMDN term
Subcutaneous infusion/injection port needle
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Subcutaneous infusion/injection port needle

Similar devices

Other devices filed under FDA product code GAA (NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE).

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)