FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rocket
DI: 05055270911612
·
Model: R29658
·
ROCKET MEDICAL PLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rocket
- Primary DI
- 05055270911612
- Version / Model
- R29658
- Catalog Number
- R29658
- Company Name
- ROCKET MEDICAL PLC
- Labeler DUNS
- 544313588
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-31
- Public Version
- 2
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- 751b9756-7ce0-42c9-ba5d-f11efa835e57
- Distribution End Date
- 2023-12-07
Device Description
Rocket Craft Spare Luer Lock Tubing Adaptor
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63642 | Surgical suction pump | An electrically-powered device, which may include noninvasive accessories, intended to generate negative pressure for aspiration of body cavities/wounds during a variety of surgical procedures (e.g., general surgery, liposuction, and laparoscopy), typically to facilitate observation; it may also be intended for airway/oral cavity clearance. It is not intended for vascular/thrombectomy use and is not dedicated to thoracic drainage or dental applications; it is not designed for surgical irrigation. The device may incorporate a pressure gauge/controls, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055270911612 | GS1 |