AccessGUDID - DEVICE: Quantum (05060434422095)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum
Version or Model: QFS2-ST-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 51-000084-00
Company Name: SPECTRUM MEDICAL LIMITED

Primary DI Number: 05060434422095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 516398679 *Terms of Use

Device Description: Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 3.0m

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35440	Cardiopulmonary bypass system air bubble/fluid level detector	A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190282	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 76 and 106 KiloPascal
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed48ffa6-d939-4e75-b5b8-c7a31f674fe4
Public Version Date: October 27, 2023
Public Version Number: 4
DI Record Publish Date: June 21, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +441242650120
Email: eusales@spectrummedical.com

Phone: 800 265 2331
Email: ussales@spectrummedical.com

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