Compression Unit Set, 650ml, with Clamp

GUDID 05707480121793

Compression Unit Upto 650ml, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)

Ambu A/S

Elastomeric infusion pump kit
Primary Device ID05707480121793
NIH Device Record Key85d239e3-c190-4df2-8570-30da61e96d40
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompression Unit Set, 650ml, with Clamp
Version Model Number418000650
Company DUNS305682023
Company NameAmbu A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Device Dimensions

Total Volume650 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween -50 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480121755 [Primary]
GS105707480121793 [Package]
Contains: 05707480121755
Package: [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEBPump, Infusion, Elastomeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-19

Devices Manufactured by Ambu A/S

05707480159154 - Ambu® SureSight® Blade2025-05-16 Video Laryngoscope Blade
05707480159109 - Ambu® SureSight® Blade2025-05-15 Video Laryngoscope Blade
05707480159123 - Ambu® SureSight® Blade2025-05-15 Video Laryngoscope Blade
05707480159192 - Ambu® SureSight® Blade2025-05-15 Video Laryngoscope Blade
05707480159222 - Ambu® SureSight® Blade2025-05-15 Video Laryngoscope Blade
05707480157167 - Ambu® aScope™ Duodeno 22025-04-07 Duodenoscope
05707480159246 - Ambu® SureSight® Blade2024-12-23 Video Laryngoscope Blade
05707480159277 - Ambu® SureSight® Blade2024-12-23 Video Laryngoscope Blade

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.