Premier Value
GUDID 10840986016636
FPPL Premier Value SPS +/-
PHARMACY VALUE ALLIANCE, LLC
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical| Primary Device ID | 10840986016636 |
| NIH Device Record Key | 3b217ec3-a914-40df-95c5-857c56dced0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premier Value |
| Version Model Number | One Step Pregnancy Test |
| Company DUNS | 089138159 |
| Company Name | PHARMACY VALUE ALLIANCE, 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 | true |
Customer Support Contacts
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 800-899-7353 |
| xx@xx.xx | |
| Phone | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840986016639 [Primary] |
| GS1 | 10840986001670 [Package] Contains: 00840986016639 Package: Shipping Case [6 Units] In Commercial Distribution |
| GS1 | 10840986016636 [Package] Contains: 00840986016639 Package: Shipping Case [24 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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-01-31 |
| Device Publish Date | 2016-08-30 |
On-Brand Devices [Premier Value ]
| 10840986030120 | Sterile Saline Wound Wash. Packaged in an Aerosol (BOV) can. |
| 40840986027510 | A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use t |
| 10840986021098 | PLPL Premier Value DPS Early |
| 40840986019713 | A hand-held, battery-powered, electronic instrument designed to measure a patient's body tempera |
| 10840986016643 | FPPL Premier Value DPS +/- |
| 10840986016636 | FPPL Premier Value SPS +/- |
| 10840986037006 | FPPL Premier Value DPS +/- Blue Cap |
| 10840986036993 | FPPL Premier Value SPS +/- Blue Cap |
| 20840986016541 | PVA ASSORT FINGER COVERS |
| 20840986016510 | PVA CLEAR TABLET CUTTER |
| 20840986016435 | PVA TABLET CRUSHER |
| 20840986015858 | PVA 150 QUIET!PLEASE 10PR EAR PLUGS |
| 10840986036634 | Wound Care Variety Pack |
| 10840986021555 | Sterile Wound Closure Strips- 1/4"x4" |
| 10840986037105 | Premier Value DPS +/- Blue Cap 2 ct |
Trademark Results [Premier Value]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREMIER VALUE 78208206 3357001 Live/Registered |
PHARMACY VALUE ALLIANCE, LLC 2003-01-29 |
 PREMIER VALUE 75164203 2113837 Dead/Cancelled |
MINNESOTA FIRE AND CASUALTY COMPANY 1996-09-11 |
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