| Primary Device ID | 00827002030145 |
| NIH Device Record Key | 522a81f8-cebe-4f7a-aefc-5a83c81d9ff7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cook-Swartz |
| Version Model Number | G03014 |
| Catalog Number | DP-SDP002 |
| Company DUNS | 056867526 |
| Company Name | Cook Vandergrift Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Temperature limits to which the medical device can be safely exposed is -40 to +60 degrees Celsius. Humidity limitation - Non-condensing environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. Temperature limits to which the medical device can be safely exposed is -40 to +60 degrees Celsius. Humidity limitation - Non-condensing environment. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002030145 [Primary] |
| JOP | TRANSDUCER, ULTRASONIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-12 |
| Device Publish Date | 2016-09-24 |
| 00827002030145 | Cook-Swartz Doppler Flow Probe Long Cuff |
| 00827002213647 | Cook-Swartz Doppler Flow Probe Extension Cable |
| 00827002213630 | Cook-Swartz Doppler Flow Probe Standard Cuff |