OC-Auto
GUDID 00816917026763
OC-Auto SENSOR io Personal Use Kit for VA Bay Pines, FL
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Faecal occult blood IVD, reagent| Primary Device ID | 00816917026763 |
| NIH Device Record Key | c40e4fdb-860b-4f16-8129-4fa0c1c4029c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OC-Auto |
| Version Model Number | OCPUIO-VA1 2334487 |
| Company DUNS | 078413594 |
| Company Name | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816917026763 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191147
FDA Product Code
| OOX | Automated Occult Blood Analyzer |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-23 |
| Device Publish Date | 2024-12-13 |
On-Brand Devices [OC-Auto]
| 00816917024547 | Personal Use Kit OC-Auto, for Yale New Haven Medical |
| 00816917024530 | Personal Use Kit OC-Auto, for Bronson Methodist Hospital Lab |
| 00816917024523 | Personal Use Kit OC-Auto, for Middletown Medical |
| 00816917024516 | Personal Use Kit OC-Auto, no mailer, for customers |
| 00816917024486 | Personal Use Kit OC-Auto, for UPHT |
| 00816917024479 | Personal Use Kit OC-Auto, for LASF |
| 00816917024462 | Personal Use Kit OC-Auto, for LAGL |
| 00816917024455 | Personal Use Kit OC-Auto, for LAMV |
| 00816917024448 | Personal Use Kit OC-Auto, for Huntington Int Med Gro |
| 00816917024424 | Personal Use Kit OC-Auto, for MCHC |
| 00816917024417 | Personal Use Kit OC-Auto, for SLHP |
| 00816917024400 | Personal Use Kit OC-Auto, Custom Kit for Virginia Physicians |
| 00816917024394 | Personal Use Kit OC-Auto, for Valley Care Hlth Sys |
| 00816917024387 | Personal Use Kit OC-Auto, Custom Kit for UNC |
| 00816917024370 | Personal Use Kit OC-Auto, for Univ of MO |
| 00816917024363 | Personal Use Kit OC-Auto, Custom Kit for Umass Memorial Hospital Med Center |
| 00816917024356 | Personal Use Kit OC-Auto, Custom Kit for UM4 |
| 00816917024349 | Personal Use Kit OC-Auto, for Univ of Miami |
| 00816917024332 | Personal Use Kit OC-Auto, Custom Kit for The Longstreet Clin |
| 00816917024325 | Personal Use Kit OC-Auto, Custom Kit for St Cloud Medical |
| 00816917024318 | Personal Use Kit OC-Auto, for Rockford Memorial Hosp |
| 00816917024301 | Personal Use Kit OC-Auto, for Rancho Los Amigos |
| 00816917024295 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab GEM |
| 00816917024288 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH7 |
| 00816917024271 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH6 |
| 00816917024264 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH5 |
| 00816917024257 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH4 |
| 00816917024240 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH3 |
| 00816917024233 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH2 |
| 00816917024226 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH1 |
| 00816917024219 | Personal Use Kit OC-Auto, for Prevea Health East |
| 00816917024202 | Personal Use Kit OC-Auto, Custom Kit for Path Group |
| 00816917024196 | Personal Use Kit OC-Auto, for Mem Med Center |
| 00816917024189 | Personal Use Kit OC-Auto, for MedLabs |
| 00816917024172 | Personal Use Kit OC-Auto, for McLaren Med Ctr-Macomb |
| 00816917024165 | Personal Use Kit OC-Auto, for McLaren Oakland |
| 00816917024158 | Personal Use Kit OC-Auto, for McLaren Flint Med Labs |
| 00816917024141 | Personal Use Kit OC-Auto, for Monroe Clinic |
| 00816917024134 | Personal Use Kit OC-Auto, Custom Kit for Lovelace Health Plan |
| 00816917024127 | Personal Use Kit OC-Auto, Custom Kit for W.T Evjue Clin |
| 00816917024110 | Personal Use Kit OC-Auto, Custom Kit for Jyc & Mrsh E Clin |
| 00816917024103 | Personal Use Kit OC-Auto, Custom Kit for LAC Itasca, IL |
| 00816917024097 | Personal Use Kit OC-Auto, Custom Kit for LAC Roybal |
| 00816917024080 | Personal Use Kit OC-Auto, Custom Kit for LAC El Monte |
| 00816917024073 | Personal Use Kit OC-Auto, Custom Kit for Jefferson Medical Center |
| 00816917024066 | Personal Use Kit OC-Auto, for Jackson Madison CtyGenHos |
| 00816917024059 | Personal Use Kit OC-Auto, for Jackson Clinic |
| 00816917024042 | Personal Use Kit OC-Auto, Custom Kit for HI West Mgmt Grp |
| 00816917024035 | Personal Use Kit OC-Auto, for Gunderson Hlth System |
| 00816917024028 | Personal Use Kit OC-Auto, for Dynacare Lab |
Trademark Results [OC-Auto]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OC-AUTO 76597320 3022594 Live/Registered |
Eiken Kagaku Kabushiki Kaisha 2004-06-15 |
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