FDA.reportPublic FDA data

HG 100 Humidifier Guard

Primary DI
M996HG1000
Brand
HG 100 Humidifier Guard
Company
INSTRUMENTATION INDUSTRIES, INCORPORATED
Model
HG 100
Catalog number
HG 100
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.
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYHDrain, Tee (Water Trap)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYHDrain, Tee (Water Trap)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M996HG1001PackageHIBCC5In Commercial Distribution
M996HG1002PackageHIBCC10In Commercial Distribution
M996HG1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit condensate trap, reusableA 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.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
4128541133raqa@iiimedical.com

Regulatory Flags#

DUNS number
053146767
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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M996KC212D0KC 212-D 90 degree Angle Wye ConnectorKC 212-DKC 212-D2019-05-11
M996KC213D0KC 213-D 60 degree Angle Wye ConnectorKC 213-DKC 213-D2019-05-11
M996KC213D6KC 213-D 60 degree Angle Wye ConnectorKC 213-DKC 213-D2019-05-11
M996NC125850NC 12585 Nose ClipNC 12585NC 125852024-07-16
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M996SH75BK0SH 75-BK Barbed Tubing AdapterSH 75-BK - BlackSH 75-BK2017-03-31
M996SH75BL0SH 75-BL Barbed Tubing AdapterSH 75-BL - BlueSH 75-BL2017-03-31
M996SH75C0SH 75-C Barbed Tubing AdapterSH 75-C - ClearSH 75-C2017-03-31
M996SH75G0SH 75-G Barbed Tubing AdapterSH 75-G - GreenSH 75-G2017-03-31
M996SH75W0SH 75-W Barbed Tubing AdapterSH 75-W - WhiteSH 75-W2017-03-31
M996SH75Y0SH 75-Y Barbed Tubing AdapterSH 75-Y - YellowSH 75-Y2017-03-31
M996BE1690BE 169 Oxygen Tank Wrench with Security CableBE 1692017-05-31
M996BE169W0BE 169-W Oxygen Tank WrenchBE 169-W2017-05-31

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