AccessGUDID - DEVICE: MPS® Extension Tubing, 6 ft. x 1/8 in. (00634624701144)

GUDID

Device Identifier (DI) Information

Brand Name: MPS® Extension Tubing, 6 ft. x 1/8 in.
Version or Model: 7001104
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7001104
Company Name: QUEST MEDICAL INC

Primary DI Number: 00634624701144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041810693 *Terms of Use

Device Description: No description.

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?
16163	Cardioplegia solution administration kit	A collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTR	Heat-Exchanger, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953838	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: 81edc5d3-5c32-4233-8d08-96539e24f242
Public Version Date: October 19, 2021
Public Version Number: 4
DI Record Publish Date: June 15, 2016