FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Newport Medical
DI: 10884521542389
·
Model: OM1001P
·
Newport Medical Instruments, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Newport Medical
- Primary DI
- 10884521542389
- Version / Model
- OM1001P
- Company Name
- Newport Medical Instruments, Inc.
- Labeler DUNS
- 050334275
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-03-08
- Public Version Status
- Update
- Public Device Record Key
- 07afa126-7952-48b4-be58-455d3f3f8535
- Distribution End Date
- 2021-02-23
Device Description
Oxygen Analyzer
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
- 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 |
|---|---|---|---|---|
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE | Anesthesiology | 868.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35219 | Respiratory oxygen monitor, line-powered | A mains electricity (AC-powered) instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range; it may also include appropriate temperature-compensated electrodes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521542389 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973282 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 2.91 | Inch | |
| Length | 1.44 | Inch | |
| Width | 0.9 | Inch |