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Rainbow Tie 301PRV

by Pepper Medical, Inc.

Rainbow Tie 301PRV is a Class I device made by Pepper Medical, Inc., listed in FDA GUDID since 17 Apr 2020 (UDI-DI 10850014574380), 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 Number10850014574380 UDI-DI Date17 Apr 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  • Withdrawn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
Rainbow Tie
Generic name
Tracheostomy tube neck holder, single-use
Model / Ref / Catalog
301PRV
Primary DI / UDI-DI
10850014574380
FDA product code
CBH
GMDN term
Tracheostomy tube neck holder, single-use
Device class
Class I
Regulation number
868.5770
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)