AccessGUDID - DEVICE: CB 23 Flowmeter / Air Compressor Adapter (M996CB230)

GUDID

Device Identifier (DI) Information

Brand Name: CB 23 Flowmeter / Air Compressor Adapter
Version or Model: CB 23
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CB 23
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996CB230
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: The CB 23 Flowmeter / Air Compressor Adapter connects a flowmeter or air compressor directly to large-bore 22 mm I.D. tubing. Can be used with high gas flows for CPAP. Has a security chain to help prevent loss.

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?
64445	Respiratory gas output switch	A non-powered device connected between a respiratory gas (e.g. oxygen) supply (e.g., wall outlet, cylinder) and one or more delivery devices (e.g., tubing, masks) intended to enable a user to turn the gas supply on and off, or to switch between alternative delivery devices; it is not an anaesthesia gas manifold. The manual switching component may be in the form of a lever that holds the delivery device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

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: Yes

Sterilization Method [?]
High-level Disinfectant

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: 3008c639-2bb7-47a2-b123-7dbe99494321
Public Version Date: November 04, 2019
Public Version Number: 3
DI Record Publish Date: July 30, 2018