n.a.
- Primary DI
- 04250105608403
- Brand
- n.a.
- Company
- VBM Medizintechnik GmbH
- Model
- 52-08-300
- Device description
- Pressure Infusion Cuff 3000 / 5000 ml; for irrigation purposes
- Published
- 2020-08-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KZD | Infusor, Pressure, For I.V. Bags |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KZD | Infusor, Pressure, For I.V. Bags | General Hospital | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04250105608403 | Direct Marking | GS1 | 0 | |
| 14250105608400 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04250105608403 | 04250105608403 | 4250105608403 |
| 14250105608400 | 14250105608400 | |
GMDN Terms
| Term | Definition |
|---|
| Intravenous pressure infusor, manual | A manually-operated device designed to increase the rate of an intravenous (IV) solution given to a patient by applying pressure directly to the infusion bag. There are two main designs: 1) a flexible bag made of textile or clear plastic with a pocket to hold the infusion bag and an inflatable pressure chamber or cuff that, when inflated, applies the desired pressure -- included is a squeeze bulb for the operator to create the pressure, a line clamp, and a pressure gauge; and 2) a design similar to the first, but where the pressure is created typically using a mechanical screw or spring mechanism. This is a reusable device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | keep dry, keep away from sunlight and heat |
Contacts
| Phone | Email |
|---|
| +49745495960 | info@vbm-medical.de |
Regulatory Flags
- DUNS number
- 324869601
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- 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
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
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