AccessGUDID - DEVICE: BabyFix Cocoon (07640178060104)

GUDID

Device Identifier (DI) Information

Brand Name: BabyFix Cocoon
Version or Model: BabyFix Cocoon
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1107
Company Name: Pearl Technology AG

Primary DI Number: 07640178060104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480151859 *Terms of Use

Device Description: Positioning aid for the immobilization of new - borns (2 to 5 kg) during MR imaging.

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):	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?
61131	Radiological general body-part positioner	A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXH	Cradle, Patient, Radiologic

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: a625b712-d0af-4b00-b8cb-c9dfdf21b005
Public Version Date: May 19, 2022
Public Version Number: 1
DI Record Publish Date: May 11, 2022