AccessGUDID - DEVICE: Adult Ventimyst Dual Heated Wire B/S 1.6m (63") Kit 1 (05055788769989)

GUDID

Device Identifier (DI) Information

Brand Name: Adult Ventimyst Dual Heated Wire B/S 1.6m (63") Kit 1
Version or Model: 038-31-252U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FLEXICARE MEDICAL LIMITED

Primary DI Number: 05055788769989
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 504406273 *Terms of Use

Device Description: No description.

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:	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?
33706	Carpal lunate prosthesis	A sterile implantable device designed to replace the lunate bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal), that may reflect the shape of the native bone. Short-term fixation is typically performed with sutures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 38a30d8f-92b1-4dd4-9c57-25cd50781005
Public Version Date: December 30, 2024
Public Version Number: 4
DI Record Publish Date: February 12, 2018