Primary Device ID | 10711234520055 |
NIH Device Record Key | 4c5cc17f-e702-4290-b27f-b08cfc3a6379 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hemochron Whole Blood Coagulation System |
Version Model Number | HRS.110-L |
Catalog Number | HRS.110-L |
Company DUNS | 079299318 |
Company Name | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
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 | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com | |
Phone | 1-800-678-0710 |
ilsd_ra.na@werfen.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10711234520055 [Primary] |
JPA | System, Multipurpose For In Vitro Coagulation Studies |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2022-08-31 |
Device Publish Date | 2016-09-22 |
10711234540060 | Temperature Verification Tube |
10711234540053 | Electronic System Verification Tube |
10711234540022 | Data Manager V3.0 |
10711234520062 | Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Demonstration) |
10711234520055 | Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Loaner) |
10711234520048 | Hemochron Whole Blood Coagulation System - Hemochron Response Instrument Refurbished |
10711234520017 | Hemochron Whole Blood Coagulation System - Hemochron Response Instrument |
10711234202111 | Kaolin Protamine Dose Assay - 40 tubes/box |
10711234202104 | Kaolin Protamine Response Test 40 tubes/box |
10711234202098 | Kaolin Protamine Response Test 40 tubes/box |
10711234202081 | Kaolin Heparin Response Test 40 tubes/box |
10711234202067 | Celite Protamine Response Test 40 tubes/box |
10711234202050 | Celite Protamine Response Test 40 tubes/box |
10711234202036 | Heparin Response Test 40 tubes/box |
10711234102206 | ACT Whole Blood Quality Control 40/box |
10711234102183 | RxDx Whole Blood Quality Control Protamine 40/box |
10711234102176 | RxDx Whole Blood Quality Control Heparin 40/box |
10711234101391 | Kaolin ACT Tubes - 95 tubes/box |
10711234101384 | Celite ACT Tubes - 95 tubes/box |
10711234101230 | Celite Protamine Dose Assay - 40 tubes/box |
10711234101094 | ACT Tubes 95 tubes/box |
10711234540114 | Temperature Verification Tube |