DEVICE: Zephyr™ (05414734501712)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47267 | Single-chamber implantable pacemaker, rate-responsive |
A battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NVZ | Pulse generator, permanent, implantable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P880086 | 146 |
P880086 | 304 |
P880086 | 307 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit |
Storage Environment Temperature: between -5 and 50 Degrees Celsius |
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit |
Handling Environment Temperature: between -5 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 10.4 Milliliter |
Device Record Status
9ab0bef0-9af2-4d6b-8d72-d130e2042e59
February 05, 2021
5
February 03, 2017
February 05, 2021
5
February 03, 2017
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 |
---|---|
HIBCC | H75856260 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com