AccessGUDID - DEVICE: Paediatric Mask; Infant (14250105630531)

GUDID

Device Identifier (DI) Information

Brand Name: Paediatric Mask; Infant
Version or Model: 88-11-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VBM Medizintechnik GmbH

Primary DI Number: 14250105630531
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324869601 *Terms of Use
Previous DI: 14250105628514

Device Description: #1; 15 mm OD.

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?
35176	Anaesthesia face mask, reusable	A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYW	Device, Rebreathing

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
Special Storage Condition, Specify: Keep away from sunlight and heat.
Special Storage Condition, Specify: Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: #1; 15 mm O.D.

Device Record Status

Public Device Record Key: 7feca470-a775-40fc-89e0-c2d363257411
Public Version Date: May 05, 2025
Public Version Number: 1
DI Record Publish Date: April 25, 2025