| Primary Device ID | H29780010634160 |
| NIH Device Record Key | a4cb6dbb-0d5e-43f2-a71f-3c8326beb5b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 8001 Series Foley Catheter Temperature Probe |
| Version Model Number | 8001-063-416 |
| Catalog Number | 8001-063-416 |
| Company DUNS | 029351079 |
| Company Name | MEASUREMENT SPECIALTIES, 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 |
| Phone | 800-899-9783 |
| medfeedback@te.com |
| Catheter Gauge | 16 French |
| Storage Environment Temperature | Between -5 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H29780010634160 [Primary] |
| HIBCC | H29780010634161 [Package] Package: Inner Box [10 Units] In Commercial Distribution |
| HIBCC | H29780010634162 [Package] Contains: H29780010634161 Package: Outer Box [10 Units] In Commercial Distribution |
| EZL | Catheter, Retention Type, Balloon |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-07-01 |
| H29780010634160 | 8001 Series Foley Catheter Temperature Probe, 16 FR |
| H29780010634142 | 8001 Series Foley Catheter Temperature Probe, 14 FR |