FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe Scientific
DI: 00840095604383
·
Model: 165513
·
GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Basic Information
- Brand Name
- Globe Scientific
- Primary DI
- 00840095604383
- Version / Model
- 165513
- 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
- 2
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 8e55f772-68a2-4188-b3f9-c2a8ec71ed14
Device Description
Capillary tube, Plain, 10uL End-To-End, 40mm
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 |
|---|---|---|---|---|
| 35770 | Capillary blood collection tube IVD, no additive | A glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840095604383 | GS1 | ||||
| Unit of Use | 00840095610674 | GS1 |