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N/A 22101 E

by Medtronic PS Medical United States GUDID

Product code JXG

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000030421 UDI-DIDate19 Apr 2020ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

29 recalls · FDA

  • 29 recalls, same reason

    • Terminated Z-1146-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1128-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1150-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1132-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1124-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1151-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1129-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1149-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1131-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1126-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1135-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1137-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1125-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1139-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1142-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1148-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1144-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1134-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1127-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1143-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1147-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1145-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1141-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1136-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1140-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1138-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1130-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1133-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009
    • Terminated Z-1152-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009

    The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

Specification

GUDID · synced 23 Oct 2026

Trade Name
N/A
Generic Name
Cranial port/reservoir
Model / Reference
22101 E
Primary DI / UDI-DI
00763000030421
510(k) Number
FDA Product Code
JXG
GMDN Term
Cranial port/reservoir
Device Class
Class II
Regulation Number
882.5550
Commercial Distribution
In Commercial Distribution

Related devices

Category: Cranial port/reservoir

Cleared under the same submission (K874498)

Show all (12)

Other devices from Medtronic PS Medical

See all devices from Medtronic PS Medical →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
Other properties (9)
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI a8f4ba7b-5839-4855-92bf-d8dc41a751c7 35 fields · synced 23 Oct 2026