AccessGUDID - DEVICE: MCT 5 (05708590389868)

GUDID

Device Identifier (DI) Information

Brand Name: MCT 5
Version or Model: R95027
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R9502717000
Company Name: Pressalit A/S

Primary DI Number: 05708590389868
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305656662 *Terms of Use

Device Description: MCT 5 change trolley, 700 x 1700 mm, two fold-down sides, white. Manually height adjustable with foot pedal

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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?
43494	Bathing/changing table, mobile	A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off) mounted on a foldable frame with legs designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff). The device is used primarily for a patient with a disability incapable of supporting themself in an upright position for bathing. It is designed to be portable or easily moved on wheels to different locations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INW	Table, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 387e3598-dceb-4742-a612-5b2cb1b94340
Public Version Date: November 13, 2024
Public Version Number: 1
DI Record Publish Date: November 05, 2024