SmartInfuser Set, 1-6ml/hr, with MultiBolus

GUDID 05707480119387

Regulating Set 1-6 with MultiBolus, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)

Ambu A/S

Elastomeric infusion pump kit
Primary Device ID05707480119387
NIH Device Record Key77dd0062-391d-4b61-8714-41abec3f2825
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartInfuser Set, 1-6ml/hr, with MultiBolus
Version Model Number418000511
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

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
GS105707480119370 [Primary]
GS105707480119387 [Package]
Contains: 05707480119370
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

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