Identity
- Trade Name
- Klein Tumescent Infiltration Pump FDA UDI
- Generic Name
- Bedside infusion pump, single-channel FDA UDI
- Device Name
- Klein Tumescent Infiltration Pump FDA UDI
- Model / Reference
- KTIP FDA UDI
- Description
- Klein Tumescent Infiltration Pump FDA UDI
Identifiers
- Catalog Number
- KTIP FDA UDI
- Primary DI / UDI-DI
- 00816989021123 FDA UDI
- 510(k) Number
- K123822 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
- 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
Yes
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
Yes
FDA UDI
Category: Bedside infusion pump, single-channel
Klein Tumescent Infiltration Pump by Hk Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bedside infusion pump, single-channel.
- CADD — ICU MEDICAL, INC. · Class II
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- Plum — Hospira, Inc. · Class II
- Plum — Hospira, Inc. · Class II
- ICU Medical, INC. — ICU MEDICAL, INC. · Class II
- CADD — ICU MEDICAL, INC. · Class II
- BD® Alaris™ PCU Model 8015 — CareFusion 303, INC · Class II
- Dispenser DP 30 — Nouvag AG · Class II
Cleared under the same submission
K123822 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 |
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Manufacturer
- Manufacturer
- Hk Surgical Inc.
Sources (1)
- FDA UDI 902dc711-477c-44bc-9e36-c7d2dfbeaf60 35 fields · synced Jun 1, 2026