FDA UDI
In Commercial Distribution
🇺🇸 United States
HARETA
DI: 06975800988596
·
Model: PTRP001S-NS
·
Yancheng Jingwei Chemicals Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HARETA
- Primary DI
- 06975800988596
- Version / Model
- PTRP001S-NS
- Company Name
- Yancheng Jingwei Chemicals Co., Ltd
- Labeler DUNS
- 546094272
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-28
- Public Version
- 1
- Public Version Date
- 2022-12-06
- Public Version Status
- New
- Public Device Record Key
- 7fa5e6f7-a946-4da2-9d96-1f0c2df70881
Device Description
TRANSFER PIPETTE 1ML 500PCS/BOX AND 5000PCS/CASE
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LGX | Table, Examination, Medical, Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64437 | Plasma filtration/collection kit IVD | A collection of devices intended to be used for the separation through filtration and collection of plasma from a whole blood specimen for subsequent in vitro diagnostic investigation. It typically consists of a contained or encased selectively-permeable membrane, which filters the whole blood to isolate the plasma component, and additional devices for plasma collection, transfer, containment and/or transportation (e.g., syringe, collection tube, pipette tip). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16975800988593 | GS1 | BOX | 500 | In Commercial Distribution | |
| Primary | 06975800988596 | GS1 |