AccessGUDID - DEVICE: FOXSEAL - CMS (15060206630700)

GUDID

Device Identifier (DI) Information

Brand Name: FOXSEAL - CMS
Version or Model: FG05814491
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-350
Company Name: MEDTRADE PRODUCTS LIMITED

Primary DI Number: 15060206630700
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 238476068 *Terms of Use

Device Description: Occlusive dressings for open chest wounds. For use by emergency trained responders

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":	Yes
For Single-Use:	Yes
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?
46424	Pneumothorax dressing	A sterile covering applied to a chest wound that has penetrated the pleura (serous membrane covering the lungs and lining the pleural cavity) in order to temporarily treat and prevent pneumothorax (collapsed lung). The device may be self-adhesive and have a one-way valve that enables internal pressure release while preventing air entry. It is typically used by first responders [emergency medical services (EMS)] in the management of penetrating chest trauma (e.g., bullet or stab wounds). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAD	Dressing, Wound, Occlusive

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: Yes
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
Device Size Text, specify: 5.12in x 5.24 in (130.5mm x 133mm)
Length: 5.12 Inch
Width: 5.24 Inch

Device Record Status

Public Device Record Key: 8464448d-fbf7-4968-af23-fb05d098f2f5
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021