Model: 3300
Catalog: 3300
DI: 00802526628900
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
Programming System
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cf25031d-5c89-4fb2-b459-db017abe7fe1
Distribution Status:
In Commercial Distribution
DUNS Number:
106295384
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00802526628900
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47205
Name: Cardiac pulse generator programmer
Definition:
An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.
FDA Product Codes
OSR
Pacemaker/icd/crt non-implanted components
Premarket Submissions
Submission Number:
P910077
Supplement Number:
193