FDA UDI
In Commercial Distribution
🇺🇸 United States
PREMIER VALUE
DI: 00840986015854
·
Model: F408-150CD
·
PHARMACY VALUE ALLIANCE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
Basic Information
- Brand Name
- PREMIER VALUE
- Primary DI
- 00840986015854
- Version / Model
- F408-150CD
- Company Name
- PHARMACY VALUE ALLIANCE, LLC
- Labeler DUNS
- 089138159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-09-21
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 7ff0c146-f3b1-495b-87e3-ba872cc6cf60
Device Description
PVA 150 QUIET!PLEASE 10PR EAR PLUGS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EWD | Protector, Hearing (Insert) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35024 | Earplugs, single-use | A device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20840986015858 | GS1 | INNER | 6 | In Commercial Distribution | |
| Primary | 00840986015854 | GS1 | ||||
| Package | 10840986015851 | GS1 | case | 12 | In Commercial Distribution | |
| Unit of Use | 40840986015852 | GS1 |
Customer Contacts
- Phone
- 952-890-1940
- [email protected]