AccessGUDID - DEVICE: Intersept® Custom Tubing Pack (00721902453298)

GUDID

Device Identifier (DI) Information

Brand Name: Intersept® Custom Tubing Pack
Version or Model: 2G10R1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00721902453298
Issuing Agency: GS1
Commercial Distribution End Date: August 28, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: CUSTOM PACK 2G10R1 RIGHT HEART BYPASS

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:	Yes
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?
35441	Cardiopulmonary bypass system blood tubing set	A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KFM	PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973011	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: b3d5fd32-4a91-4510-af8a-9c5db56115c1
Public Version Date: December 08, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2014