Primary Device ID | 00856233005172 |
NIH Device Record Key | ff880721-c112-402e-9eb8-bb822df1959b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Model 7A |
Version Model Number | Re-manufactured, unpackaged |
Catalog Number | 0101-9999 |
Company DUNS | 800214827 |
Company Name | CARDIOCOMMAND, INC. |
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 | false |
Serial Number | true |
Manufacturing Date | true |
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 | (800) 231-6370 |
cconley@CardioCommand.com |
Handling Environment Temperature | Between 40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Handling Environment Temperature | Between 40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Handling Environment Temperature | Between 40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00856233005172 [Primary] |
LPA | System, Esophageal Pacing |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-10-05 |
Device Publish Date | 2015-04-03 |
00856233005172 | Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed |
00856233005165 | Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed |
00856233005134 | Patient lead wire for use with the Model 7A stimulator; white, right arm. |
00856233005127 | Patient lead wire for use with the Model 7A stimulator; black, left arm. |
00856233005110 | Interface cable between 7A Stimulator and Model 3 preamplifier. |
00856233005103 | Instrument cable for 7A Stimulator or Model 3 preamp. |