AccessGUDID - DEVICE: SJM™ (05414734506441)

GUDID

Device Identifier (DI) Information

Brand Name: SJM™
Version or Model: 4023
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4023
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734506441
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: ADAPTING SLEEVE KIT

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?
36102	Pacing/defibrillation lead electrical adaptor	An implantable device designed to adapt the electrical connectors of an implanted pacemaker and/or defibrillator pacing lead to a non-compatible pacemaker or defibrillator (i.e., when they do not meet connection design). This device is implanted with the pacemaker or defibrillator system.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DTD	pacemaker lead Adaptor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K921318	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: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between -5 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 3.2 Millimeter
Length: 5 Millimeter
Outer Diameter: 6 Millimeter

Device Record Status

Public Device Record Key: a6e856cb-ab97-41eb-ac7a-ed9a4a15baa5
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: April 10, 2017