FDA UDI
In Commercial Distribution
🇺🇸 United States
RapidWeld Blade Module Kit
DI: 10866305000247
·
Model: GRW-430
·
GENESIS BPS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
Basic Information
- Brand Name
- RapidWeld Blade Module Kit
- Primary DI
- 10866305000247
- Version / Model
- GRW-430
- Catalog Number
- 480-RW-2478-02
- Company Name
- GENESIS BPS LLC
- Labeler DUNS
- 141091095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2020-01-10
- Public Version
- 1
- Public Version Date
- 2020-01-20
- Public Version Status
- New
- Public Device Record Key
- f1996f12-7332-4bd5-96ec-37a24ac69f89
Device Description
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KSB | Set, Transfer (Blood/Plasma) | Hematology | 864.9875 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62054 | Laboratory tubing welder | A mains electricity (AC-powered) device intended to make a sterile connection (weld) between two segments of plastic tubing (typically blood transfer tubing during blood/blood component processing applications) in a clinical laboratory setting. It is a tabletop device which includes a blade, realignment mechanism, heating element and clamps intended to enable tubing dissection/reconnection while maintaining a closed system (sterile fluid path). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10866305000247 | GS1 | ||||
| Unit of Use | 00866305000240 | GS1 |
Customer Contacts
- Phone
- 201-708-1400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK140187 | 0 |