AccessGUDID - DEVICE: NA (04037691720791)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: CARDIOHELP Holder for mast HKH 9102-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70104.9584
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691720791
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: CARDIOHELP Holder for mast

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 service rail	A device designed to provide a secure, rapid, and safe method of mounting and organizing medical and non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in hospital wards, treatment rooms or an intensive care unit (ICU). It is usually fixed to a medical device service rail system, a medical device, or directly to a wall and in some cases it may be fixed to mobile devices. It will have a preformed cross-section incorporating a safety design compatible to the clamps expected to be mounted. It may be supplied in regular lengths which must be cut accordingly when fitted, or in prefabricated 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: f2d17407-cb28-40d3-bc2d-a3ee47a389da
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 29, 2016