FDA UDI
In Commercial Distribution
🇺🇸 United States
Mask face tent O2Star S
DI: 04048675382508
·
Model: MP01933
·
Drägerwerk AG & Co. KGaA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Mask face tent O2Star S
- Primary DI
- 04048675382508
- Version / Model
- MP01933
- Company Name
- Drägerwerk AG & Co. KGaA
- Labeler DUNS
- 315578914
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 91806817-dd72-4cf3-acc3-6d730780d1e2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | 868.5340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12893 | Oxygen administration tent, adult | A flexible enclosure designed for the top of a bed that is used to cover the head/torso of an adult patient to provide an enriched oxygen (O2) environment to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It typically consists of a metal frame covered with transparent plastic, tubing, and may have built-in humidification. It is used for the treatment of breathing and other cardiopulmonary disorders, and for patients who are adverse to oxygen delivery devices such as a nasal cannula, face mask or endotracheal (ET) tube. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048675382508 | GS1 | ||||
| Unit of Use | 04048675420507 | GS1 |
Customer Contacts
- Phone
- +494518820
- [email protected]