COVER 5441 DISPOSABLE EPG 3PK 16L
NA - 5441
Device Description
A non-sterile device, typically made of disposable transparent plastic, intended to be attached over the control panel of a pacemaker external pulse generator (EPG) to form a protective enclosure to help prevent accidental changes to the EPG control settings. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
Environmental Conditions
- 135.00
- -30.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LWP
Device Name: Implantable Pulse Generator, Pacemaker (Non-Crt)
Device Class: 3
Physical State: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Definition: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: Y
Target Area: These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 20613994300083
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 00613994300089
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A