FDA UDI
In Commercial Distribution
🇺🇸 United States
TrueCare Biomedix
DI: 30850789007650
·
Model: TCBTECR-25
·
Truecare Biomedix - USA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- TrueCare Biomedix
- Primary DI
- 30850789007650
- Version / Model
- TCBTECR-25
- Company Name
- Truecare Biomedix - USA
- Labeler DUNS
- 005457284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-10-13
- Public Version
- 1
- Public Version Date
- 2021-10-21
- Public Version Status
- New
- Public Device Record Key
- 6f902f90-09ac-4258-9e2a-5ff50f022928
Device Description
Tamper Evident Cap
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
- No
- 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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63614 | Luer-formatted protective cap | A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40850789007657 | GS1 | CASE | 400 | In Commercial Distribution | |
| Primary | 30850789007650 | GS1 | ||||
| Unit of Use | 00850789007659 | GS1 |
Customer Contacts
- Phone
- 305-593-8444
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210818 | 000 |