Identity
- Trade Name
- ReShape Infiltration Pump FDA UDI
- Generic Name
- Bedside infusion pump, single-channel FDA UDI
- Device Name
- ReShape Infiltration Pump FDA UDI
- Model / Reference
- KIP-II-RS FDA UDI
- Description
- ReShape Infiltration Pump FDA UDI
Identifiers
- Catalog Number
- KIP-II-RS FDA UDI
- Primary DI / UDI-DI
- 08169890200135 FDA UDI
- 510(k) Number
- K031432 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Bedside infusion pump, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ReShape Infiltration Pump by Hk Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K031432 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hk Surgical Inc.
Sources (1)
- FDA UDI 80292113-e0c0-47e4-8c8f-590ca1570d68 37 fields · synced Jun 1, 2026