FDA UDI
In Commercial Distribution
🇺🇸 United States
Universal Pipette Tip
DI: 00810050853590
·
Model: PT0101S
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Universal Pipette Tip
- Primary DI
- 00810050853590
- Version / Model
- PT0101S
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 1
- Public Version Date
- 2021-04-30
- Public Version Status
- New
- Public Device Record Key
- 4262650e-d9ad-44d3-bb54-da9075111682
Device Description
Universal Pipette Tips - Filter - 200 microliter - Sterile
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JRC | Micro Pipette | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42875 | Mechanical micropipette | A manually-operated device typically used in the laboratory to withdraw, transfer, and inject minute volumes of fluid materials (e.g., microlitres or smaller). The device is typically hand-held and operates through an internal mechanism powered by finger depressions of the user; it can have a single channel or a multichannel piston/cylinder assembly. The device transfers consistent volumes of substance into one or several receptacles simultaneously. The device may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810050853590 | GS1 | ||||
| Package | 10810050853597 | GS1 | Inner Box | 96 | In Commercial Distribution | |
| Package | 20810050853594 | GS1 | Outer Case | 10 | In Commercial Distribution | |
| Package | 40810050853598 | GS1 | Master Carton | 5 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 200 | Microliter |