AccessGUDID - DEVICE: Quantum (05060434422026)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum
Version or Model: QWSL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 51-000080-00
Company Name: SPECTRUM MEDICAL LIMITED

Primary DI Number: 05060434422026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 516398679 *Terms of Use

Device Description: Quantum Workstation Lite - 15"

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
36347	Cardiopulmonary bypass system roller pump	A mains electricity (AC-powered) device that is a module of a cardiopulmonary bypass system and is used to circulate the blood flow outside of the body for gas exchange and reinfusion via a roller type mechanism. It may be designed with a single or a dual rotor head that presses the blood through the extracorporeal tubing set that is connected to the oxygenator and other parts of the heart-lung bypass system. This pump can also be used to deliver cardioplegia solution at a controlled volume to the patient.	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 [?]
K173834	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: 269b602c-8b2e-4d7d-b5d9-fda67ee341f8
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: July 10, 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: No
Serial Number: Yes
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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