AccessGUDID - DEVICE: BB 4500-20D Mask/Filter Storage Box (M996BB450020D0)

GUDID

Device Identifier (DI) Information

Brand Name: BB 4500-20D Mask/Filter Storage Box
Version or Model: BB 4500-20D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BB 4500-20D
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996BB450020D0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: Wall-mounted storage box provides storage and immediate availability for emergency-use items such as oxygen masks, resuscitator bags, airways, masks, filters, etc. (The storage box does not include these items.) Dimensions: 20" Length x 8" Width x 6" Depth.

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:	No
Prescription Use (Rx):	No
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?
62736	Medical device storage mount	A permanently-fixed structure upon which a medical device (not included) is designed to be mounted for storage purposes only; the device is not intended to be operated whilst mounted to this device. It is commonly wall-mounted and may be available in a variety of designs (e.g., wall bracket), may be dedicated to a specific type of device, or non-dedicated; it is not a shelf.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYG	Mask, Oxygen

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: 7b6e7257-a82d-4517-b8b7-e87489cd90b4
Public Version Date: March 11, 2019
Public Version Number: 1
DI Record Publish Date: February 28, 2019