FDA UDI
In Commercial Distribution
🇺🇸 United States
LabChoice Transfer Pipettes, Small Bulb, 3mL Transparent
DI: 00840117331068
·
Model: 40203
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- LabChoice Transfer Pipettes, Small Bulb, 3mL Transparent
- Primary DI
- 00840117331068
- Version / Model
- 40203
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2024-12-26
- Public Version
- 1
- Public Version Date
- 2025-01-03
- Public Version Status
- New
- Public Device Record Key
- 14098a4b-5af7-441c-9c42-7b7b42b9be3f
Device Description
Sterile-Eo
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
- Yes
- 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 |
|---|---|---|---|---|
| GJW | Pipette, Pasteur | Hematology | 864.6160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63337 | Pipette tip IVD | A device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette, or a dispenser, and where the required volume of liquid (e.g., reagent, buffer, biological specimen) is drawn for delivery to a target receptacle during an in vitro diagnostic procedure. It is typically used for manual procedures or onboard automated liquid handling instruments or analysers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810180840781 | GS1 | ||||
| Primary | 00840117331068 | GS1 | ||||
| Package | 00840117329959 | GS1 | Case | 5 | In Commercial Distribution |