AccessGUDID - DEVICE: Quantum (05060434422743)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum
Version or Model: QVM2-N-TM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 51-000102-00
Company Name: SPECTRUM MEDICAL LIMITED

Primary DI Number: 05060434422743
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 516398679 *Terms of Use

Device Description: Quantum Ventilation Module - NIST (Tube Mount)

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?
31714	Cardiopulmonary bypass system gas control unit	A device that is a module of a cardiopulmonary bypass system and that is used to control and measure the flow of gas supplied into the oxygenator. It is calibrated for a specific gas and has a high degree of accuracy at low flows. It may be a flowmeter.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTX	Gas Control Unit, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202733	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: 31bd61ee-8344-41f3-9241-dfd509e0831d
Public Version Date: December 18, 2020
Public Version Number: 1
DI Record Publish Date: December 10, 2020

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

Phone: +441242650120
Email: eusales@spectrummedical.com

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