AccessGUDID - DEVICE: RUSCH (04026704302154)

GUDID

Device Identifier (DI) Information

Brand Name: RUSCH
Version or Model: IPN050004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 264030
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 04026704302154
Issuing Agency: GS1
Commercial Distribution End Date: September 21, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: St. Bartholomew Catheter with 250cc Balloon

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):	Yes
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?
34912	Barium enema catheter	A flexible tube designed to administer barium, a contrast medium, into the lower gastrointestinal tract by way of the rectum, for radiographic visualization of the area; it may additionally be intended for washing of the colon. The rubber or plastic tube may also be used for colonoscopy and can have a silicone rubber retention balloon tip for the examination of incontinent persons. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K841036	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: b40301db-e3d9-44b8-8162-f65b5e104fca
Public Version Date: June 19, 2024
Public Version Number: 5
DI Record Publish Date: September 16, 2016