Primary Device ID | 00810591020086 |
NIH Device Record Key | 0c934309-667d-4f98-ba99-2d0c3d5cd5f6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FIRMap |
Version Model Number | MAC001NS |
Catalog Number | MAC001NS |
Company DUNS | 080174723 |
Company Name | ABBOTT |
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 | false |
Lot Batch | true |
Serial Number | false |
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 |
Phone | +1(650)681-3470 |
aepcustomerservice@abbott.com | |
Phone | +1(650)681-3470 |
aepcustomerservice@abbott.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810591020086 [Primary] |
MTD | CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-02 |
00810591020246 | FIRMap Catheter Fan Out Cable (2m) - Abbott (Global), Non-Sterile |
00810591020086 | FIRMap Mapping Adapter Connector |
00810591020079 | FIRMap Extension Cable - Global, Non-Sterile |
00810591020062 | FIRMap Fan Out Cable - US, Non-Sterile |
00810591020031 | FIRMap Catheter 70mm, PACKAGED - Abbott (Global) |
00810591020024 | FIRMap Catheter 60mm, PACKAGED - Abbott (Global) |
00810591020017 | FIRMap Catheter 50mm, PACKAGED - Abbott (Global) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FIRMAP 85427524 4547992 Live/Registered |
Topera, Inc. 2011-09-20 |