FDA UDI
In Commercial Distribution
🇺🇸 United States
Haemonetics
DI: 20887691306376
·
Model: 400-03
·
HAEMONETICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Haemonetics
- Primary DI
- 20887691306376
- Version / Model
- 400-03
- Company Name
- HAEMONETICS CORPORATION
- Labeler DUNS
- 057827420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-20
- Public Version
- 4
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 1c3a9194-bee8-4d3b-a81f-cc4140caf044
Device Description
Bacerial Detection System for Quality Control Testing of Platelet Products
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MZC | System,detection,bacterial, for platelet transfusion products | Microbiology | 866.2560 | 1 |
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 |
|---|---|---|---|---|---|---|
| Package | 30887691306373 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 20887691306376 | GS1 |
Customer Contacts
- Phone
- +1(800)-537-2802
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK070063 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 40 Degrees Celsius