FDA UDI
In Commercial Distribution
🇺🇸 United States
Xenon Master Administration Set
DI: 00857863007451
·
Model: MN1212
·
Medi/Nuclear Corporation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Xenon Master Administration Set
- Primary DI
- 00857863007451
- Version / Model
- MN1212
- Company Name
- Medi/Nuclear Corporation, Inc.
- Labeler DUNS
- 079628327
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-09
- Public Version
- 4
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- ca07ae26-fcf4-4016-830b-589f0c0d2c34
Device Description
Mouthpiece, Rigid w/Injection Port & Bacteria Filter, Flexible Tubing, Ventilator Circuit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYT | System, Rebreathing, Radionuclide | Radiology | 892.1390 | 2 |
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 | 00857863007536 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 00857863007451 | GS1 |
Customer Contacts
- Phone
- 800-321-5981
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature