FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RM3 Tool Kit
DI: B154R39100010043
·
Model: RM3 Tool Kit
·
WATERS MEDICAL SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RM3 Tool Kit
- Primary DI
- B154R39100010043
- Version / Model
- RM3 Tool Kit
- Catalog Number
- 3910001.004
- Company Name
- WATERS MEDICAL SYSTEMS, LLC
- Labeler DUNS
- 556957871
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-27
- Public Version
- 5
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 91f2c804-3a6f-4061-8fd1-ff414755e0f4
- Distribution End Date
- 2023-12-15
Device Description
RM3 Tool Kit
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KDN | System, Perfusion, Kidney | Gastroenterology, Urology | 876.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48039 | Kidney donor-organ preservation/transport perfusion set | A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B154R39100010043 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K971571 | 000 |