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MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube SJS-LP-60-T-J

by Bayer Medical Care Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00616258021188 UDI-DI Date6 Sep 2018ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0745-2019 FDA Class II initiated 14 Dec 2018

    If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube
Generic Name
Radiographic procedure tubing
Model / Ref / Catalog
SJS-LP-60-T-J
Primary DI / UDI-DI
00616258021188
510(k) Number
FDA Product Code
DXT
GMDN Term
Radiographic procedure tubing
Device Class
Class II
Regulation Number
870.1650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiographic procedure tubing

Cleared under the same submission (K173773)

Show all (12)

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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