FDA UDI
In Commercial Distribution
🇺🇸 United States
Tri-Tech Forensics, Inc.
DI: 00869373000204
·
Model: TUG10
·
TRI-TECH FORENSICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Tri-Tech Forensics, Inc.
- Primary DI
- 00869373000204
- Version / Model
- TUG10
- Company Name
- TRI-TECH FORENSICS, INC.
- Labeler DUNS
- 105878292
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-25
- Public Version
- 1
- Public Version Date
- 2020-03-04
- Public Version Status
- New
- Public Device Record Key
- f9a214d2-680a-4615-b25a-56eea74e0ebe
Device Description
10 ml Grey Stoppered Blood Tube, Each
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57905 | Non-evacuated blood collection tube IVD, potassium oxalate/sodium fluoride | A non-evacuated sterile glass or plastic tube, sealed with a stopper, containing the anticoagulant potassium oxalate and the antiglycolytic agent sodium fluoride. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10869373000201 | GS1 | Case | 10 | In Commercial Distribution | |
| Package | 20869373000208 | GS1 | Inner Pack | 10 | In Commercial Distribution | |
| Primary | 00869373000204 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K971111 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 10 | Milliliter |