SapphirePlus Infusion Kit - US 17000-033-0001

GUDID 07290109150161

Q-CORE MEDICAL LTD

General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered General-purpose infusion pump, line-powered Bedside infusion pump Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel Bedside infusion pump, single-channel

Primary Device ID	07290109150161
NIH Device Record Key	51c959d8-46b7-4db8-889f-a199e6fea371
Commercial Distribution Status	In Commercial Distribution
Brand Name	SapphirePlus Infusion Kit - US
Version Model Number	17000-033-0001
Catalog Number	17000-033-0001
Company DUNS	533108028
Company Name	Q-CORE MEDICAL LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com
Phone	1-800-241-4002
Email	sapphireGCM@icumed.com

Operating and Storage Conditions

Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109150161 [Direct Marking]
GS1	17290109150151 [Previous]
GS1	17290109150229 [Primary]
GS1	27290109150158 [Package] Contains: 17290109150151 Package: cardboard box [8 Units] Discontinued: 2018-02-22 Not in Commercial Distribution
GS1	27290109150226 [Package] Contains: 17290109150229 Package: cardboard box [8 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141389

FDA Product Code

FRN	Pump, Infusion

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2018-02-22

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