GUDID 00681490153621

ACCESS 6984M EXTENDER BIP IS-1

MEDTRONIC, INC.

Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor Pacing/defibrillation lead electrical extension adaptor

Primary Device ID	00681490153621
NIH Device Record Key	38df3bb0-a28f-4e3b-8878-acf5c2c373be
Commercial Distribution Status	In Commercial Distribution
Version Model Number	6984M
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490153621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915724

FDA Product Code

DTD	pacemaker lead Adaptor

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-06-10

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