FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxygen Sensor
DI: 04036616010979
·
Model: OOMLF202-2R
·
Honeywell Healthcare Solutions GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Oxygen Sensor
- Primary DI
- 04036616010979
- Version / Model
- OOMLF202-2R
- Catalog Number
- E1002607
- Company Name
- Honeywell Healthcare Solutions GmbH
- Labeler DUNS
- 330943838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-14
- Public Version
- 1
- Public Version Date
- 2024-08-22
- Public Version Status
- New
- Public Device Record Key
- 0d228941-0d27-4824-b47b-932fdac3a240
Device Description
Oxygen Sensor OOMLF202-2R / REF 27990
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | Anesthesiology | 868.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13538 | Respiratory oxygen sensor | A device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines the percentage of O2 in medical gases used in an enclosed atmosphere (e.g., an anaesthesia or ventilator circuit, oxygen tent, oxygen therapy device/system tubing) inspired by a patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04036616010979 | GS1 |
Customer Contacts
- Phone
- +493841360313
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082655 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 28 | Millimeter | |
| Width | 29 | Millimeter | |
| Weight | 23 | Gram |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 700 – 1250 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius