AccessGUDID - DEVICE: RUSCH (04026704030774)

GUDID

Device Identifier (DI) Information

Brand Name: RUSCH
Version or Model: IPN004372
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 204802-000180
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 04026704030774
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Sengstaken-Blakemore tube, 3-way

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?
35416	Oesophageal varices haemostatic tube	A flexible, hollow cylinder with an inflatable balloon(s) and aspiration port(s) intended to be non-surgically inserted into the oesophagus and stomach, through the nose or mouth, to tampon bleeding oesophageal varices. The device is also known as a Sengstaken, Blakemore, Linton or Minnesota tube. 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 [?]
K981203	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
Special Storage Condition, Specify: Keep dry; Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 18 French

Device Record Status

Public Device Record Key: fb66be18-16a0-4b8e-a36e-d61702661abe
Public Version Date: January 25, 2021
Public Version Number: 7
DI Record Publish Date: September 16, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
44026704030772	20	24026704030778		In Commercial Distribution	Carton
24026704030778	2	04026704030774		In Commercial Distribution	Box

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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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