| Primary Device ID | 00811925030030 |
| NIH Device Record Key | 134343c0-1714-4503-ace3-0492e9bc0108 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADS Medical |
| Version Model Number | T1-CK50-ADSM |
| Company DUNS | 602085672 |
| Company Name | W.H.P.M. INC. |
| Device Count | 50 |
| DM Exempt | false |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811925030016 [Unit of Use] |
| GS1 | 00811925030030 [Primary] |
| KHE | Reagent, Occult Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-04-30 |
| Device Publish Date | 2018-03-29 |
| 00811925030078 | ADS Medical iFOB Collection Tube, 50 Purple Cap Collection Tubes with Short Label per Box |
| 00811925030061 | ADS Medical iFOB Collection Tube, 30 Purple Cap Collection Tubes with Short Label per Box |
| 00811925030054 | ADS Medical iFOB Test, 50 Cassettes per Box |
| 00811925030047 | ADS Medical iFOB Test, 30 Cassettes per Box |
| 00811925030030 | ADS Medical iFOB Test Kit, 50 Cassettes and 50 Collection Tubes per Box Kit without Mailer |
| 00811925030023 | ADS Medical iFOB Test Kit, 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer |
| 00811925030009 | ADS Medical iFOB Test Kit, 30 Cassettes and 50 Collection Tubes per Box Kit with 50 Mailers |