Identity
- Trade Name
- ACTion Block Pump, 200ml, 1-6 ml/hr FDA UDI
- Generic Name
- Elastomeric infusion pump kit FDA UDI
- Device Name
- ACTion Block 200, 1-6ml/hr, no catheter set FDA UDI
- Model / Reference
- 418201200 FDA UDI
- Description
- ACTion Block 200, 1-6ml/hr, no catheter set FDA UDI
Identifiers
- Catalog Number
- 418201200 FDA UDI
- Primary DI / UDI-DI
- 05707480110940 FDA UDI
- 510(k) Number
- K072053 FDA UDI
- FDA Product Code
- MEB FDA UDI
- GMDN Term
- Elastomeric infusion pump kit 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 200 Milliliter FDA UDI
Category: Elastomeric infusion pump kit
ACTion Block Pump, 200ml, 1-6 ml/hr by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Elastomeric infusion pump kit.
- LMA — TELEFLEX INCORPORATED · Class II
- ON-Q* Pain Relief System — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- AVANOS* — Avanos Medical, Inc. · Class II
- AVANOS — Avanos Medical, Inc. · Class II
- LMA — TELEFLEX INCORPORATED · Class II
- Halyard — Avanos Medical, Inc. · Class II
- LMA — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K072053 also covers:
- ACTion Block Pump, 1000ml, 1-6 ml/hrMultiBolus II — Ambu A/S
- ACTion Block Pump, 1000ml, 5-15 ml/hrMultiBolus II — Ambu A/S
- ACTion Block Pump, 200ml, 5-15 ml/hr — Ambu A/S
- ACTion Block Pump, 400ml, 1-6 ml/hr — Ambu A/S
- ACTion Block Pump, 400ml, 1-6 ml/hrMultiBolus II — Ambu A/S
- ACTion Block Pump, 400ml, 5-15 ml/hr — Ambu A/S
- ACTion Block Pump, 400ml, 5-15 ml/hr, Splitter — Ambu A/S
- ACTion Block Pump, 400ml, 5-15 ml/hrMultiBolus II — Ambu A/S
- ACTion Block Pump, 650ml, 1-6 ml/hr — Ambu A/S
- ACTion Block Pump, 650ml, 1-6 ml/hr, MultiBolus — Ambu A/S
- ACTion Block Pump, 650ml, 1-6 ml/hrMultiBolus II — Ambu A/S
- ACTion Block Pump, 650ml, 5-15 ml/hr — Ambu A/S
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
- Ambu A/S
Sources (1)
- FDA UDI 9e6bcf98-1ed9-4d84-865f-8da1621669e9 38 fields · synced May 30, 2026