FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Roscoe Medical
DI: 00092237615751
·
Model: ROS-50044
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Roscoe Medical
- Primary DI
- 00092237615751
- Version / Model
- ROS-50044
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 4
- Public Version Date
- 2023-08-23
- Public Version Status
- Update
- Public Device Record Key
- 6650ae1f-620e-4f14-8dcc-30dce8e3ab24
- Distribution End Date
- 2019-05-07
Device Description
Roscoe Single Lumen Conserver,
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 |
|---|---|---|---|---|
| NFB | Conserver, Oxygen | Anesthesiology | 868.5905 | 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 |
|---|---|---|---|---|---|---|
| Package | 50092237615756 | GS1 | CA | 25 | Not in Commercial Distribution | 2019-05-07 |
| Primary | 00092237615751 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]