FDA UDI
In Commercial Distribution
🇺🇸 United States
Procure
DI: 10840330700372
·
Model: 010-8058-7-50
·
Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Procure
- Primary DI
- 10840330700372
- Version / Model
- 010-8058-7-50
- Catalog Number
- 010-8058-7-50
- Company Name
- Twin Med, LLC
- Labeler DUNS
- 107071289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-03
- Public Version
- 2
- Public Version Date
- 2023-01-18
- Public Version Status
- Update
- Public Device Record Key
- 65fadd66-8045-4209-9c68-d5dbdec73435
Device Description
Mask Venturi Percent O2-Lock Assembly Humidity Cup W 7' Kink Resistant Tubing No Mask
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| BYG | Mask, Oxygen | Anesthesiology | 868.5580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35142 | Aerosol face mask, rebreathing, single-use | A flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30840330700376 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 10840330700372 | GS1 |
Customer Contacts
- Phone
- 612-819-1635
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius