FDA UDI
In Commercial Distribution
🇺🇸 United States
NOxBOXi NOXKIT EMER
DI: 00850046301124
·
Model: 1
·
Linde Gas & Equipment Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NOxBOXi NOXKIT EMER
- Primary DI
- 00850046301124
- Version / Model
- 1
- Catalog Number
- LGENOXKIT-EMER
- Company Name
- Linde Gas & Equipment Inc.
- Labeler DUNS
- 042845636
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-01
- Public Version
- 2
- Public Version Date
- 2023-10-17
- Public Version Status
- Update
- Public Device Record Key
- a15c76ff-67e9-4c83-8703-eb5319afa17d
Device Description
NOxBOXi NOXKIT EMER patient Kit for use with the NOxBOXi nitric oxide delivery device.
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
- 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
- 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 |
|---|---|---|---|---|
| MRP | Analyzer, Nitric Oxide | Anesthesiology | 868.2380 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37266 | Nitric oxide delivery unit, system-based | A mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850046301131 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00850046301124 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius