COVER EPG 53922US 3 PK MKT US
NA - 53922US
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
- 95.00
- 10.00
- 158.00
- -40.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DTE
Device Name: Pulse-Generator, Pacemaker, External
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.3600
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 00643169305120
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