AccessGUDID - DEVICE: Breathing hose 22/22 (N/P) 110 (04048675023371)

GUDID

Device Identifier (DI) Information

Brand Name: Breathing hose 22/22 (N/P) 110
Version or Model: 2165678
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Drägerwerk AG & Co. KGaA

Primary DI Number: 04048675023371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315578914 *Terms of Use

Device Description: No description.

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Ventilator breathing circuit, reusable	A non-sterile assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Ventilator breathing circuit, reusable

A non-sterile assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
BZO	Set, Tubing And Support, Ventilator (W Harness)
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 43f2771f-bc2c-4e04-981d-12552c3e8f2d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 24, 2015