Sapphire External Battery Pack

GUDID 27290109153999

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 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 ID27290109153999
NIH Device Record Key2430f66a-b187-4bf8-9b77-13c53d67fab1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire External Battery Pack
Version Model 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

Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109153995 [Direct Marking]
GS117290109153992 [Primary]
GS127290109153999 [Package]
Contains: 17290109153992
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-23
Device Publish Date2022-05-15

On-Brand Devices [Sapphire External Battery Pack]

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