Primary Device ID | 00856298006169 |
NIH Device Record Key | 579ccc3e-ebc6-46cc-86ae-223337185128 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HolterCare |
Version Model Number | HolterCare |
Catalog Number | 100087 |
Company DUNS | 808204957 |
Company Name | SCOTTCARE CORPORATION, THE |
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 | false |
OTC Over-The-Counter | false |
Phone | 216-362-0550 |
service@scottcare.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00856298006169 [Primary] |
DQK | Computer, Diagnostic, Programmable |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-19 |
00856298006428 - EZLink-R | 2024-05-31 |
00856298006435 - EZLink-C | 2024-05-31 |
00856298006008 - Chroma | 2019-11-08 The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) co |
00856298006015 - Chroma2 | 2019-11-08 |
00856298006022 - TeleSenseRCM | 2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events |
00856298006039 - TeleSense-E | 2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events |
00856298006220 - Chroma 5 Lead Patient Cable | 2019-11-08 5 lead ECG patient cable to be used with the Chroma device. |
00856298006312 - Chroma 7 Lead Patient Cable | 2019-11-08 7 lead ECG patient cable to be used with the Chroma device. |