AccessGUDID - DEVICE: Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator (05060491614129)

GUDID

Device Identifier (DI) Information

Brand Name: Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator
Version or Model: CME40004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CME40004
Company Name: CHALICE MEDICAL LIMITED

Primary DI Number: 05060491614129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 236289299 *Terms of Use

Device Description: The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.

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:	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?
62085	Extracorporeal membrane oxygenation system circuit	A complete portable assembly of noninvasive, non-powered devices intended to be used as part of an extracorporeal bypass system to provide short-term or prolonged (i.e., extra-surgical) mechanical circulatory life support during extracorporeal membrane oxygenation (ECMO) [sometimes referred to as extracorporeal lung support (ECLS)]. It usually includes a centrifugal pump mechanism, defoamer, heat exchanger, membrane oxygenator, and integrated tubing or independent tubing sets. It is intended to be used in conjunction with the capital components (e.g., pump drive unit, gas control unit, heating/cooling unit) and invasive components (e.g., cannulae) of the bypass. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTZ	Oxygenator, Cardiopulmonary Bypass
DTR	Heat-Exchanger, Cardiopulmonary Bypass
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201642	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
Special Storage Condition, Specify: to be stored in a dry, room temperature area and protected from direct solar or UV light.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ec173ca-873b-4257-9a10-15f37cd39656
Public Version Date: January 03, 2024
Public Version Number: 2
DI Record Publish Date: November 07, 2023