FDA UDI
In Commercial Distribution
🇺🇸 United States
INOmax DSIR Plus
DI: 00867538000106
·
Model: 10007
·
Mallinckrodt Manufacturing LLC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INOmax DSIR Plus
- Primary DI
- 00867538000106
- Version / Model
- 10007
- Company Name
- Mallinckrodt Manufacturing LLC
- Labeler DUNS
- 828331780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-11
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4f35c4ba-e370-4264-b345-71ee94368da6
Device Description
INOmax DSIR Plus
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MRQ | Analyzer, nitrogen dioxide | Anesthesiology | 868.2385 | 2 |
| MRO | APPARATUS, NITRIC OXIDE, BACKUP DELIVERY | Anesthesiology | 868.5165 | 2 |
| MRP | ANALYZER, NITRIC OXIDE | Anesthesiology | 868.2380 | 2 |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00867538000106 | GS1 |
Customer Contacts
- Phone
- +1(877)566-9466
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131686 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57 – 110 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Could be "Do not subject to sunlight" or "transport only in closed trucks" etc.
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 57 – 110 KiloPascal