Mini Cradle with Splitter- US 17000-026-0007

GUDID 07290109150000

Q-CORE MEDICAL LTD

Intravenous pole multi-outlet holder
Primary Device ID07290109150000
NIH Device Record Key19c0e6c2-5b20-4692-87f3-79fe92d76423
Commercial Distribution StatusIn Commercial Distribution
Brand NameMini Cradle with Splitter- US
Version Model Number17000-026-0007
Catalog Number17000-026-0007
Company DUNS533108028
Company NameQ-CORE MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
Emailsapsapphiregcm@pfe.icumed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109150000 [Direct Marking]
GS117290109150007 [Previous]
GS117290109150014 [Previous]
GS117290109150045 [Primary]
GS117290109150113 [Primary]
GS127290109150011 [Package]
Contains: 17290109150014
Package: cardboard box [20 Units]
Discontinued: 2016-10-23
Not in Commercial Distribution
GS127290109150042 [Package]
Contains: 17290109150045
Package: cardboard box [20 Units]
In Commercial Distribution
GS127290109150110 [Package]
Contains: 17290109150113
Package: cardboard box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRZAccessories, Pump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-23

Devices Manufactured by Q-CORE MEDICAL LTD

07290109154213 - Sapphire Multi-Pump Mounting Device2022-11-14
17290109153985 - Infusion Pouch 500mL2022-11-14
17290109154043 - Homecare Large Backpack2022-11-14
17290109154050 - Communication Cable -US 2022-11-14
27290109153937 - Multi-Pump Bracket Kit - US (4 units)2022-11-14
27290109154071 - Multi-Pump Mounting System compatible with IPS- A2022-05-24
17290109153046 - AP403-01 - MICROBORE WITH VENTED/NON-VENTED SPIKE2022-05-23
27290109153067 - AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA2022-05-23

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