FDA UDI
In Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270921055
·
Model: R58800-08-SD
·
ROCKET MEDICAL PLC
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270921055
- Version / Model
- R58800-08-SD
- Catalog Number
- R58800-08-SD
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 19471739-ab0f-447f-8de7-2e2bfca19168
Device Description
Rocket Multipurpose Safety Drain 8Fg x 15cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32337 | Abdominal paracentesis needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument used to perform therapeutic or diagnostic aspiration of fluids/air from the abdominal cavity. It may be used for the placement/operation of a paracentesis catheter or used directly without a catheter. It is typically made of high-grade stainless steel and may have an attached stopcock to control the aspiration process. The device is commonly used to remove ascites fluid from the peritoneal cavity. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055270963840 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 05055270921055 | GS1 |
Customer Contacts
- Phone
- +4401914196988
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8.0 | French | |
| Length | 15.0 | Centimeter |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 40 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 101 – 101 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 1 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 30 Degrees Celsius