Identity
- Trade Name
- Ambu® ACTion™ Block Pump FDA UDI
- Generic Name
- Elastomeric infusion pump kit FDA UDI
- Device Name
- Action Block, 650 mL, Dual Regulator (1-6 mL/hr), Y-Tubing FDA UDI
- Model / Reference
- 419110650C FDA UDI
- Description
- Action Block, 650 mL, Dual Regulator (1-6 mL/hr), Y-Tubing FDA UDI
Identifiers
- Catalog Number
- 419110650C FDA UDI
- Primary DI / UDI-DI
- 05707480155880 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
No
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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 650 Milliliter FDA UDI
Category: Elastomeric infusion pump kit
Ambu® ACTion™ Block Pump by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Elastomeric infusion pump kit.
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- 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, 1-6 ml/hr — 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
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
- Ambu A/S
Sources (1)
- FDA UDI df479dc2-109e-4d05-b3ea-d44022849130 38 fields · synced Jun 1, 2026