NA

Basic Information

• Brand Name: NA
• Primary DI: 00721902066825
• Version / Model: 672637
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 6
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: eca53b3f-828b-44fe-bf2f-2efd4b82ca5a
• Distribution End Date: 2019-02-25

Device Description

ADAPTER 672637 Y DF1 ADAP/EXT KIT US

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTB	permanent pacemaker Electrode	Cardiovascular	870.3680	3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00721902066825	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P920015	022
P920015	217

Device Sizes

Type	Value	Unit	Text
Length	37.0	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 104 Degrees Fahrenheit