FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe Scientific
DI: 00840095606165
·
Model: 3826
·
GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Basic Information
- Brand Name
- Globe Scientific
- Primary DI
- 00840095606165
- Version / Model
- 3826
- Company Name
- GLOBE SCIENTIFIC INC.
- Labeler DUNS
- 106793995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2019-11-26
- Public Version
- 1
- Public Version Date
- 2019-12-04
- Public Version Status
- New
- Public Device Record Key
- a15371b9-ec43-4ad4-b022-536a1cfe1116
Device Description
Quick-Prep Urinalysis Pipette, 500/Bag, 6 Bags/Unit
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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63460 | Fluid transfer tube, general-purpose | A sterile, flexible, blunt tubular device made of plastic materials designed to be used for the manual transfer of several types of medical fluids (e.g., solutions, syrups) between a first container (e.g., a vial) and a second container [e.g., a syringe]; it is not dedicated to a particular type of fluid or clinical procedure. It is not intended to puncture the seal of a vial/container, nor is it intended for patient contact. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840095606165 | GS1 | ||||
| Unit of Use | 00840095611107 | GS1 | ||||
| Package | 00840095606172 | GS1 | Case | 6 | In Commercial Distribution |