FDA UDI
In Commercial Distribution
🇺🇸 United States
Gas Sampling Line 120 x .048 x .108 M/M CO-EX
DI: 00859290006267
·
Model: 90100
·
TRUER MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Gas Sampling Line 120 x .048 x .108 M/M CO-EX
- Primary DI
- 00859290006267
- Version / Model
- 90100
- Catalog Number
- 90100
- Company Name
- TRUER MEDICAL, INC.
- Labeler DUNS
- 003530786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-30
- Public Version
- 2
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- ef0bf43d-16d8-4100-899d-4b33a4dadc1b
Device Description
Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit.
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 |
|---|---|---|---|---|---|---|
| Primary | 00859290006267 | GS1 | ||||
| Package | 20859290006261 | GS1 | Carton | 50 | In Commercial Distribution | |
| Package | 10859290006264 | GS1 | Carton | 100 | In Commercial Distribution | |
| Package | 40859290006265 | GS1 | Carton | 8 | In Commercial Distribution | |
| Package | 30859290006268 | GS1 | Carton | 500 | In Commercial Distribution |
Customer Contacts
- Phone
- 7146289785
- [email protected]