FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe Scientific
DI: 00840095604369
·
Model: 164113
·
GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- Globe Scientific
- Primary DI
- 00840095604369
- Version / Model
- 164113
- Company Name
- GLOBE SCIENTIFIC INC.
- Labeler DUNS
- 106793995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- 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
- 25027688-c7dc-4765-95ad-c8f84941ca36
Device Description
Capillary tube, EDTA, 75mm, marked at: 32mm & 64mm, 100/vial
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 |
|---|---|---|---|---|
| GIO | Tube, Collection, Capillary Blood | Hematology | 864.6150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58154 | Capillary blood transfer tube IVD, EDTA | A non-sterile glass or plastic capillary blood transfer tube coated internally with the anticoagulant ethylenediaminetetraacetic acid (EDTA), and intended to be attached to a non-evacuated blood collection tube to assist with the transfer of blood drops from the blood collection site into the collection tube using a capillary action. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840095604369 | GS1 | ||||
| Unit of Use | 00840095610650 | GS1 |