FDA UDI
In Commercial Distribution
🇺🇸 United States
Precision Medical Inc.
DI: 00855887006733
·
Model: 504877-
·
Precision Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Precision Medical Inc.
- Primary DI
- 00855887006733
- Version / Model
- 504877-
- Company Name
- Precision Medical, Inc.
- Labeler DUNS
- 112569116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-02
- Public Version
- 4
- Public Version Date
- 2021-04-23
- Public Version Status
- Update
- Public Device Record Key
- b686ab59-c5e8-4ce3-a680-6c6e66932618
Device Description
SENSOR,O2,PM5900
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
- 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 |
|---|---|---|---|---|
| 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 | 00855887006733 | GS1 |