FDA.reportPublic FDA data

KM 030 Disposable Connector with LCD Thermometer

Primary DI
M996KM0300
Brand
KM 030 Disposable Connector with LCD Thermometer
Company
INSTRUMENTATION INDUSTRIES, INCORPORATED
Model
KM 030
Catalog number
KM 030
Device description
The KM 030 Disposable Connector with LCD Thermometer is intended for use in a ventilator circuit, or a heated aerosol circuit. The LCD thermometer gives approximate temperature readings only and is not a substitute for definitive temperature monitoring. Dimensions: 22mm O.D. x 22mm I.D. Single Patient Use. Molded of High Density Polyethylene.
Published
2016-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M996KM0305PackageHIBCC50In Commercial Distribution
M996KM0300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Straight/elbow breathing circuit connector, single-useA device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Moist Heat or Steam Sterilization""]"

Contacts#

Phone, Email table
PhoneEmail
412-854-1133raqa@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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M996SR75C0SR 75-C Swivel Barbed Tubing AdapterSR 75-C ClearSR 75-C2026-04-01
M996KC211D0KC 211-D 60 degree Angle Wye ConnectorKC 211-DKC 211-D2019-05-11
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
M996SH74BK0SH 74-BK Barbed Tubing AdapterSH 74-BK - BlackSH 74-BK2017-03-31
M996SH74BL0SH 74-BL Barbed Tubing AdapterSH 74-BL - BlueSH 74-BK2017-03-31
M996SH74C0SH 74-C Barbed Tubing AdapterSH 74-C - ClearSH 74-C2017-03-31
M996SH74G0SH 74-G Barbed Tubing AdapterSH 74-G - GreenSH 74-G2017-03-31
M996SH74W0SH 74-W Barbed Tubing AdapterSH 74-W - WhiteSH 74-W2017-03-31
M996SH74Y0SH 74-Y Barbed Tubing AdapterSH 74-Y - YellowSH 74-Y2017-03-31
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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Primary DI, Brand, Company table
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