AccessGUDID - DEVICE: NA (04037691717968)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Cardiohelp Mobile Holder HKH 8860
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70105.0897
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691717968
Issuing Agency: GS1
Commercial Distribution End Date: September 25, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: CARDIOHELP-i mobile holder. The CARDIOHELP-i Mobile Holder is for connection to the CARDIOHELP Base Plate or CARDIOHELP Wall Holder incl. CARDIOHELP mobile holder CARDIOHELP protection cover

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?
35954	Medical device rail	A device in the form of a narrow bar designed to be fixed on the wall for mounting and organizing medical devices [e.g., in hospital wards, treatment rooms, intensive care units (ICU)]; the equipment to be supported is not included. It may be used in conjunction with clamps and/or poles. It is available in various lengths.	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 [?]
K102726	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1037233-e0a8-4acc-9d3a-956bcc7c1c39
Public Version Date: December 11, 2024
Public Version Number: 5
DI Record Publish Date: February 29, 2016