Catheter Set, 140mm Cut-to Size, 6" Introducer  

GUDID 05707480119134

Catheter set (140mm cut-to size + 6" introducer), stand alone, complementary accessory(to be used with ACTion Block and ACTion Fuser ONLY)

Ambu A/S

Elastomeric infusion pump kit
Primary Device ID05707480119134
NIH Device Record Key446744fd-ff18-447b-ae8a-af9a51d25077
Commercial Distribution StatusIn Commercial Distribution
Brand NameCatheter Set, 140mm Cut-to Size, 6" Introducer  
Version Model Number418000502
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

Length140 Millimeter

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
GS105707480119110 [Primary]
GS105707480119127 [Package]
Contains: 05707480119110
Package: [5 Units]
In Commercial Distribution
GS105707480119134 [Package]
Contains: 05707480119127
Package: [40 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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