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RediTube™ 8100RTC

by Carefusion

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885403296178 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3172-2026 FDA Class II initiated 31 Jul 2026

    The 6Fr suction catheter could not pass through the samples smoothly.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
RediTube™
Generic Name
Basic endotracheal tube, single-use
Model / Ref / Catalog
8100RTC
Primary DI / UDI-DI
10885403296178
510(k) Number
FDA Product Code
BTR
GMDN Term
Basic endotracheal tube, single-use
Device Class
Class II
Regulation Number
868.5730
GUDID distribution status
Not in Commercial Distribution
Size
Lumen/Inner Diameter — 10.0 Millimeter
Outer Diameter — 13.60 Millimeter

Related devices

Cleared under the same submission (K042683)

Show all (12)

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No