FDA UDI
In Commercial Distribution
🇺🇸 United States
KENTEX
DI: 00810003754769
·
Model: 550011
·
KENTRON HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KENTEX
- Primary DI
- 00810003754769
- Version / Model
- 550011
- Company Name
- KENTRON HEALTHCARE, INC.
- Labeler DUNS
- 618825723
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-19
- Public Version
- 1
- Public Version Date
- 2024-02-27
- Public Version Status
- New
- Public Device Record Key
- af9a421e-cec8-4299-b272-a409d197cd00
Device Description
CONNECTOR 1/8" NPT MALE TO 1/4" BARB
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZA | Connector, Airway (Extension) | Anesthesiology | 868.5810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45110 | Oxygen quick-connect coupling, male | A male connecting device used to connect to a medical gas pipeline system or other gas source allowing a user to rapidly connect and disconnect oxygen (O2) dependent devices to the O2 supply. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection. It is used to connect into an O2 terminal unit or female connector. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810003754769 | GS1 |