Primary Device ID | 00885672001520 |
NIH Device Record Key | b86f0e09-45f3-42a1-96bf-a0682230225a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HELIOS |
Version Model Number | H05RH110U |
Company DUNS | 101835833 |
Company Name | Oscor 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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00885672001520 [Primary] |
LDF | Electrode, Pacemaker, Temporary |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-08-02 |
Device Publish Date | 2015-10-16 |
00885672001872 | HRHCK05110S |
00885672001865 | HRHCK05110U |
00885672001537 | H05RH110S |
00885672001520 | H05RH110U |
00836559007265 | HK05110U |
00836559007258 | HK05110S |
00836559006640 | H05110U |
00836559006633 | H05110S |