AccessGUDID - DEVICE: Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 (08051160301201)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum PureFlow Standard Heat Exchanger Low Flow 1/4
Version or Model: HX11W-S1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SPECTRUM MEDICAL SRL

Primary DI Number: 08051160301201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436188505 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
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?
64585	Cardiopulmonary bypass system heat exchanger, single-use	A device consisting of a heat exchanging system intended to be used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for the purposes of cardiopulmonary bypass intervention or treatment. This device will typically be a module of a cardiopulmonary bypass system whereby it receives thermal transfer fluid at a specific temperature from a system heating/cooling unit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTR	Heat-Exchanger, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212688	000
K220110	000
K223879	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 73f49898-1dfb-4dfe-a232-d188ca69ea96
Public Version Date: January 05, 2024
Public Version Number: 4
DI Record Publish Date: February 16, 2022