AccessGUDID - DEVICE: KM 030 Disposable Connector with LCD Thermometer (M996KM0300)

GUDID

Device Identifier (DI) Information

Brand Name: KM 030 Disposable Connector with LCD Thermometer
Version or Model: KM 030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KM 030
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996KM0300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

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.

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:	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?
61346	Straight/elbow breathing circuit connector, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)

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
Moist Heat or Steam Sterilization

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: 2eb9692d-1fbf-4b2a-9565-ac5522b586e0
Public Version Date: November 28, 2022
Public Version Number: 6
DI Record Publish Date: October 31, 2016