FDA UDI
In Commercial Distribution
🇺🇸 United States
TrueCare Biomedix
DI: 10850789007724
·
Model: TCBEXT0.2
·
Truecare Biomedix - USA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- TrueCare Biomedix
- Primary DI
- 10850789007724
- Version / Model
- TCBEXT0.2
- Company Name
- Truecare Biomedix - USA
- Labeler DUNS
- 005457284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-12-31
- Public Version
- 1
- Public Version Date
- 2023-01-09
- Public Version Status
- New
- Public Device Record Key
- 54a298d5-22bd-47bd-83af-375761c8a55d
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58977 | Basic intravenous administration set, noninvasive | A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850789007721 | GS1 | Case | 500 | In Commercial Distribution | |
| Primary | 10850789007724 | GS1 | ||||
| Unit of Use | 00850789007727 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111351 | 000 |