AccessGUDID - DEVICE: HG 100 Humidifier Guard (M996HG1000)

GUDID

Device Identifier (DI) Information

Brand Name: HG 100 Humidifier Guard
Version or Model: HG 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HG 100
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996HG1000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: The HG 100 Humidifier Guard is intended for use with a humidifier installed within a ventilator circuit. The device allows for safe removal of condensation and patient secretions that have accumulated in the inspiratory limb of a ventilator circuit. The HG100 protects the humidifier by allowing these liquids to be collected in the device and then to be easily removed by suction when necessary.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
31286	Breathing circuit condensate trap, reusable	A non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent the leak of fluid when removed from the circuit; it does not include a moisture filter. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYH	Drain, Tee (Water Trap)

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 [?]
Hydrogen Peroxide

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: 5a6b5bf5-f5ab-4ef2-89e3-dfc1ff1fd2f8
Public Version Date: November 23, 2022
Public Version Number: 1
DI Record Publish Date: November 15, 2022