FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOPHEN™ V-L Control Plasma
DI: 03663537008320
·
Model: 223405
·
HYPHEN BIOMED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOPHEN™ V-L Control Plasma
- Primary DI
- 03663537008320
- Version / Model
- 223405
- Catalog Number
- 223405
- Company Name
- HYPHEN BIOMED
- Labeler DUNS
- 503499167
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-25
- Public Version
- 4
- Public Version Date
- 2020-08-21
- Public Version Status
- Update
- Public Device Record Key
- 7cd5f8f1-ddd3-4aa4-acf7-c1cea7ef613f
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41694 | Activated protein C resistance ratio (APCR) IVD, control | A material which is used to verify the performance of an assay intended to be used to determine the activated protein C resistance ratio (APCR) of a clinical specimen by measuring clotting time with and without added activated protein C. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03663537008320 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083729 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius