AccessGUDID - DEVICE: Biotronix Healthcare (00850005165101)

GUDID

Device Identifier (DI) Information

Brand Name: Biotronix Healthcare
Version or Model: RE-343004S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RE-343004S
Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Primary DI Number: 00850005165101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065762392 *Terms of Use

Device Description: Nebulizer with Pediatric Elongated Mask, 7ft. No Crush Tubing and Standard Connector

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):	Yes
Over the Counter (OTC):	Yes
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?
31309	Nebulizing system delivery set, single-use	A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140237	000

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: Nebulizer with Pediatric Elongated Mask, 7ft. No Crush Tubing and Standard Connector

Device Record Status

Public Device Record Key: 3ffe6b86-1616-4520-86e3-dc45b18f08bf
Public Version Date: December 24, 2019
Public Version Number: 2
DI Record Publish Date: October 05, 2019