Integrated power supply 15072-000-0010

GUDID 27290109153968

Q-CORE MEDICAL LTD

Basic power supply, reusable
Primary Device ID27290109153968
NIH Device Record Key2c9f6a7b-f93b-4765-8cc3-a0fa844d5258
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegrated power supply
Version Model Number15072-000-0010
Catalog Number15072-000-0010
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109153964 [Direct Marking]
GS117290109153961 [Primary]
GS127290109153968 [Package]
Contains: 17290109153961
Package: [20 Units]
In Commercial Distribution
GS127290109154446 [Package]
Contains: 17290109153961
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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.