FDA UDI
In Commercial Distribution
🇺🇸 United States
Anti-Drug Antibody Biomarker Specimen Collection Kit
DI: 00850025688888
·
Model: 5000833
·
Takeda Pharmaceuticals U.S.A., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Anti-Drug Antibody Biomarker Specimen Collection Kit
- Primary DI
- 00850025688888
- Version / Model
- 5000833
- Catalog Number
- 5000833
- Company Name
- Takeda Pharmaceuticals U.S.A., Inc.
- Labeler DUNS
- 041877817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-30
- Public Version
- 1
- Public Version Date
- 2023-11-07
- Public Version Status
- New
- Public Device Record Key
- 5b1a2e84-3b7e-480e-b89f-2be009cc3bf4
Device Description
The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collectingspecimens from patients receiving ELAPRASE® or VPRIV® commercial therapy for the treatment of Hunter syndrome and Gaucher disease
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850025688888 | GS1 | ||||
| Previous | 05060147022339 | GS1 |