FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe Scientific
DI: 00840095601269
·
Model: 112030
·
GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Globe Scientific
- Primary DI
- 00840095601269
- Version / Model
- 112030
- Company Name
- GLOBE SCIENTIFIC INC.
- Labeler DUNS
- 106793995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-27
- Public Version
- 3
- Public Version Date
- 2023-07-04
- Public Version Status
- Update
- Public Device Record Key
- 35fd4681-2a48-417f-a842-9a0c41efd97c
Device Description
Tube, Urine Centrifuge, 12mL, with Sediment Bulb and Flared Top, PS, Graduated to 10 mL, 500/Bag, 3 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 |
|---|---|---|---|---|
| 43761 | Centrifuge tube IVD | A tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840095601269 | GS1 | ||||
| Package | 00840095601245 | GS1 | Box | 500 | In Commercial Distribution | |
| Package | 00840095601252 | GS1 | Case | 1500 | In Commercial Distribution | |
| Package | 00840095643382 | GS1 | bag | 250 | In Commercial Distribution |