Rocket
- Primary DI
- 05055270964007
- Brand
- Rocket
- Company
- ROCKET MEDICAL PLC
- Model
- R54549-28-PK
- Catalog number
- R54549-28-PK
- Device description
- Rocket 28Fg Seldinger Drain Insert Set
- Published
- 2017-01-19
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05055270964007 | Package | GS1 | 5 | In Commercial Distribution |
| 05055270921222 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05055270964007 | 05055270964007 | 5055270964007 |
| 05055270921222 | 05055270921222 | 5055270921222 |
GMDN Terms
| Term | Definition |
|---|
| Pneumothorax catheter insertion set | A collection of devices used to puncture the chest wall to enable insertion of a dedicated catheter for the aspiration of a simple pneumothorax or decompression of a tension pneumothorax. It typically consists of a scalpel to make a stab incision and a needle to assist the entry of the catheter with obturator assembly (to protect the internal organs upon entry). Once the catheter is in place, the needle is retracted to allow the flow of air/fluid from within the chest cavity. The set may contain suture for the attachment of the catheter to the skin. It is typically used for accident and emergency (A&E) situations (immediate care or chest crush injury). This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Catheter Gauge | 28 | French |
| Length | 30 | Centimeter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 101 KiloPascal | 101 KiloPascal | |
| Handling Environment Humidity | 1 Percent (%) Relative Humidity | 70 Percent (%) Relative Humidity | |
| Handling Environment Temperature | -5 Degrees Celsius | 40 Degrees Celsius | |
| Storage Environment Atmospheric Pressure | 101 KiloPascal | 101 KiloPascal | |
| Storage Environment Humidity | 1 Percent (%) Relative Humidity | 70 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -5 Degrees Celsius | 30 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +4401914196988 | gudid@rocketmedical.com |
Regulatory Flags
- DUNS number
- 544313588
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
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