SapphirePlus Infusion Kit - US 17000-033-0001

GUDID 07290109150161

Q-CORE MEDICAL LTD

General-purpose infusion pump, line-powered
Primary Device ID07290109150161
NIH Device Record Key51c959d8-46b7-4db8-889f-a199e6fea371
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphirePlus Infusion Kit - US
Version Model Number17000-033-0001
Catalog Number17000-033-0001
Company DUNS533108028
Company NameQ-CORE MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@icumed.com
Phone1-800-241-4002
EmailsapphireGCM@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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109150161 [Direct Marking]
GS117290109150151 [Previous]
GS117290109150229 [Primary]
GS127290109150158 [Package]
Contains: 17290109150151
Package: cardboard box [8 Units]
Discontinued: 2018-02-22
Not in Commercial Distribution
GS127290109150226 [Package]
Contains: 17290109150229
Package: cardboard box [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, 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 Date2018-02-22

Devices Manufactured by Q-CORE MEDICAL LTD

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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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