| Primary Device ID | 00011822337373 |
| NIH Device Record Key | f7f10cea-6c93-429b-ba49-02bfe2091f94 |
| Commercial Distribution Discontinuation | 2021-02-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Rite Aid Pharmacy |
| Version Model Number | Family Planning Ovulation Predictor One Step |
| Company DUNS | 483609579 |
| Company Name | SPD SWISS PRECISION DIAGNOSTICS GMBH |
| Device Count | 7 |
| DM Exempt | false |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx | |
| Phone | 1-800-899-7353 |
| xx@xx.xx |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00011822337373 [Primary] |
| GS1 | 00633472000140 [Unit of Use] |
| GS1 | 10011822337370 [Package] Package: Shipping Case [6 Units] Discontinued: 2021-02-11 Not in Commercial Distribution |
| CEP | Radioimmunoassay, Luteinizing Hormone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-02-12 |
| Device Publish Date | 2019-03-01 |
| 10011822037249 | A convenience kit consisting of 1 Rite Aid Pharmacy Digital Pregnancy Test and 1 Rite Aid Pharma |
| 10011822018163 | RITE AID DPS +/- 2ct Blue Cap |
| 10011822515808 | Rite Aid DPS Early Bi-Ling |
| 10011822510469 | FPPL Rite Aid TPS +/- (ER) |
| 10011822473030 | Rite Aid TPS Early Result |
| 10011822380062 | PLPL Rite Aid DPS Early Result |
| 00011822337373 | WWOT Rite Aid OVS |
| 10011822306642 | FPPL Rite Aid DPS +/- (ER) |
| 00011822096973 | FPPL Rite Aid SPS +/- (ER) |