Regulating Set 5-15 with parallel MultiBolus IISta 418000540

GUDID 05707480111411

Regulating Set 5-15 ml/hr with MB II

Ambu A/S

Elastomeric infusion pump kit
Primary Device ID05707480111411
NIH Device Record Key307bf7b7-ee70-4b56-ad3f-7a4e018faaaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegulating Set 5-15 with parallel MultiBolus IISta
Version Model Number418000540
Catalog Number418000540
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480111398 [Primary]
GS105707480111404 [Package]
Contains: 05707480111398
Package: [2 Units]
In Commercial Distribution
GS105707480111411 [Package]
Contains: 05707480111404
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEBPUMP, INFUSION, ELASTOMERIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-13
Device Publish Date2018-07-13

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