FDA UDI
In Commercial Distribution
🇺🇸 United States
INOmax
DI: 00810055280148
·
Model: 90855
·
Mallinckrodt Manufacturing LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- INOmax
- Primary DI
- 00810055280148
- Version / Model
- 90855
- Company Name
- Mallinckrodt Manufacturing LLC
- Labeler DUNS
- 828331780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-29
- Public Version
- 1
- Public Version Date
- 2024-04-08
- Public Version Status
- New
- Public Device Record Key
- bcee5238-129b-48c5-9e52-81ca907bdffb
Device Description
Evolve Injector Tube
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MRN | Apparatus, Nitric Oxide Delivery | Anesthesiology | 868.5165 | 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 | 10810055280145 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00810055280148 | GS1 |
Customer Contacts
- Phone
- +1(877)566-9466
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222930 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57 – 110 KiloPascal