CURAPLEX
- Primary DI
- 00810071631894
- Brand
- CURAPLEX
- Company
- BOUND TREE MEDICAL, LLC
- Model
- 670231-KIT
- Catalog number
- 670231-KIT
- Device description
- THS Vibrapep Kit
- Published
- 2021-04-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| BWF | SPIROMETER, THERAPEUTIC (INCENTIVE) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| BWF | Spirometer, Therapeutic (Incentive) | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810071631894 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810071631894 | 00810071631894 | 810071631894 | 0810071631894 |
GMDN Terms
| Term | Definition |
|---|
| PEEP valve, single-use | A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device. |
Regulatory Flags
- DUNS number
- 070556204
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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