Identity
- Trade Name
- ACTion Block Pump, 200ml, 5-15 ml/hr FDA UDI
- Generic Name
- Elastomeric infusion pump kit FDA UDI
- Device Name
- ACTion Block 200, 5-15ml/hr, no catheter set FDA UDI
- Model / Reference
- 418202200 FDA UDI
- Description
- ACTion Block 200, 5-15ml/hr, no catheter set FDA UDI
Identifiers
- Catalog Number
- 418202200 FDA UDI
- Primary DI / UDI-DI
- 05707480110964 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, 5-15 ml/hr 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
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- 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, 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 |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA UDI 7d3ec129-0d2b-42eb-a339-7156d8c0a232 38 fields · synced May 30, 2026