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Ambu® ACTion™ Block Pump

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name
Ambu® ACTion™ Block Pump FDA UDI
Generic Name
Elastomeric infusion pump kit FDA UDI
Device Name
Action Block, MBII, 650 mL, 1-6 mL/hr Regulator FDA UDI
Model / Reference
419150650C FDA UDI
Description
Action Block, MBII, 650 mL, 1-6 mL/hr Regulator FDA UDI

Identifiers

Catalog Number
419150650C FDA UDI
Primary DI / UDI-DI
05707480155767 FDA UDI
510(k) Number
K131247 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
MRI Safety
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

Similar devices

Also classified as Elastomeric infusion pump kit.

Cleared under the same submission

K131247 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambu A/S

Sources (1)

  • FDA UDI 13a06dc5-ef4d-4aae-8a37-edcde4d06be9 38 fields · synced May 31, 2026