CVP Health N/A
GUDID 10761706168537
McLane (CVP Health) DPS +/-
SPD SWISS PRECISION DIAGNOSTICS GMBH
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical| Primary Device ID | 10761706168537 |
| NIH Device Record Key | 41581a0e-e687-4863-9520-473cb2b778c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CVP Health |
| Version Model Number | One Step Pregnancy Test |
| Catalog Number | N/A |
| Company DUNS | 483609579 |
| Company Name | SPD SWISS PRECISION DIAGNOSTICS GMBH |
| Device Count | 2 |
| 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 | true |
Customer Support Contacts
| 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 | |
| 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 |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00633472000126 [Unit of Use] |
| GS1 | 00761706168530 [Primary] |
| GS1 | 10761706168537 [Package] Contains: 00761706168530 Package: Shipping Case [24 Units] In Commercial Distribution |
| GS1 | 20761706168534 [Package] Contains: 00761706168530 Package: Shipping Case [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042280
FDA Product Code
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
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 | 2024-04-12 |
| Device Publish Date | 2024-04-04 |
On-Brand Devices [CVP Health]
| 10761706168490 | MCLane One Step Pregnancy Cassette |
| 10761706168537 | McLane (CVP Health) DPS +/- |
Trademark Results [CVP Health]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CVP HEALTH 88205324 not registered Live/Pending |
CEI Physicians P.S.C., Inc. 2018-11-26 |
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