FDA UDI
In Commercial Distribution
🇺🇸 United States
CO EX LINE 96'X.048'X112' M/M
DI: 00859290006434
·
Model: 90116
·
TRUER MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CO EX LINE 96'X.048'X112' M/M
- Primary DI
- 00859290006434
- Version / Model
- 90116
- Catalog Number
- 90116
- Company Name
- TRUER MEDICAL, INC.
- Labeler DUNS
- 003530786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-09
- Public Version
- 1
- Public Version Date
- 2022-12-19
- Public Version Status
- New
- Public Device Record Key
- a7dbe359-dcda-45f3-8d12-c6cdb2036a34
Device Description
Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45566 | Gas-sampling/monitoring respiratory tubing, single-use | A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10859290006431 | GS1 | Case | 500 | In Commercial Distribution | |
| Primary | 00859290006434 | GS1 |
Customer Contacts
- Phone
- 7146289785
- [email protected]