AccessGUDID - DEVICE: NA (00681490153553)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 6981M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00681490153553
Issuing Agency: GS1
Commercial Distribution End Date: May 02, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: ACCESS 6981M KIT EXTENDER UNI IS-1

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?
45850	Pacing/defibrillation lead electrical extension adaptor	An implantable device used to provide a functional and modified connection between existing pacing leads (e.g., IS-1 leads) and an implantable pacing/defibrillation device (e.g., pacemaker, defibrillator). It typically consists of a small connector block to enable attachment to the pacing leads (i.e., when they do not meet connection design) and extension leads to increase the reach of the pacing leads. During implantation the surgeon uses a tool to tighten the connections (e.g., a Hex wrench), and a medical adhesive to seal the connections from body fluid contamination. This device facilitates the implantation of the pacing device and/or is useful if two leads need to be implanted.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DTD	pacemaker lead Adaptor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911827	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
Storage Environment Temperature: less than 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a7f96946-f25f-47c9-a923-347b17d84671
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: June 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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