| Primary Device ID | 20711234311032 |
| NIH Device Record Key | 687b9b41-966a-49d8-bd59-dc1df7132b03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgicutt Bleeding Time Blotting Paper |
| Version Model Number | SUP100I |
| Catalog Number | SUP100I |
| Company DUNS | 079299318 |
| Company Name | ACCRIVA DIAGNOSTICS HOLDINGS, INC. |
| Device Count | 100 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 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 | 1-800-643-1640 |
| UDI@accriva.com | |
| Phone | 1-800-643-1640 |
| UDI@accriva.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 | |
| 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 | |
| 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 | 00711234311038 [Unit of Use] |
| GS1 | 20711234311032 [Primary] |
| FRL | Fiber, Medical, Absorbent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-19 |
| Device Publish Date | 2016-09-22 |
| 10711234515044 - GEM Hemochron 100 System | 2022-10-14 GEM Hemochron 100 System (Loaner) |
| 10711234530153 - Avoximeter Whole Blood Oximeter | 2022-09-01 Avoximeter Whole Blood Oximeter System - Instrument (Demonstration) |
| 10711234540114 - Hemochron Whole Blood Coagulation System | 2022-09-01 Temperature Verification Tube |
| 10711234101094 - Hemochron Whole Blood Coagulation System | 2022-08-31 ACT Tubes 95 tubes/box |
| 10711234101230 - Hemochron Whole Blood Coagulation System | 2022-08-31 Celite Protamine Dose Assay - 40 tubes/box |
| 10711234101384 - Hemochron Whole Blood Coagulation System | 2022-08-31 Celite ACT Tubes - 95 tubes/box |
| 10711234101391 - Hemochron Whole Blood Coagulation System | 2022-08-31 Kaolin ACT Tubes - 95 tubes/box |
| 10711234102176 - Hemochron Whole Blood Coagulation System | 2022-08-31 RxDx Whole Blood Quality Control Heparin 40/box |