AccessGUDID - DEVICE: NA (00643169466203)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 44513
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC PS MEDICAL, INC.

Primary DI Number: 00643169466203
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089055867 *Terms of Use

Device Description: RES 44513 CSF-LUMBOPERITONEAL RES 20MM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61524	Cerebrospinal fluid shunt valve/port/reservoir	An implantable component of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt designed to regulate the pressure and/or flow of cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine or brain to the peritoneal cavity or heart right atrium in the management of raised CSF pressure (e.g., caused by hydrocephalus), and to permit hypodermic infusion/injection of materials into the central nervous system via the subarachnoid space; it may also be used for drainage of CSF. It consists of a subcutaneous puncturable dome with catheter connections, and a non-return and/or mechanical valve that typically opens at a pre-set pressure and may be non-invasively adjusted.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K831396	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e67b35f6-5fd3-44d7-a8f0-526bf5dcda7c
Public Version Date: April 07, 2021
Public Version Number: 4
DI Record Publish Date: July 10, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES