Sapphire External Battery Pack 15079-111-0001

GUDID 07290109150086

6 AA 1.5V Alkaline . Output 10Vdc

Q-CORE MEDICAL LTD

Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack
Primary Device ID07290109150086
NIH Device Record Keydb18d422-cbc3-402b-9285-8621779a0578
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire External Battery Pack
Version Model Number15079-111-0001
Catalog Number15079-111-0001
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 Perscriptionfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109150086 [Direct Marking]
GS117290109150083 [Primary]
GS127290109150080 [Package]
Contains: 17290109150083
Package: cardboard box [10 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 Date2016-09-20

On-Brand Devices [Sapphire External Battery Pack]

072901091500866 AA 1.5V Alkaline . Output 10Vdc
2729010915399915079-111-0001
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