AccessGUDID - DEVICE: Replacement Part 24 Inch Grey Tubing (00606959015210)

GUDID

Device Identifier (DI) Information

Brand Name: Replacement Part 24 Inch Grey Tubing
Version or Model: 00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1006833
Company Name: Respironics, Inc.

Primary DI Number: 00606959015210
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: Replacement Part 24 Inch Grey Tubing

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
35113	Non-heated respiratory humidifier	A device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (reservoir) for the water, a top piece that functions as a detachable lid (typically a screw lid with a gastight seal), and a tube that protrudes into the water to divert the gas below the water level. This device, commonly known as a bubble humidifier, does not heat the water. It has connectors: 1) one (e.g., a winged nut) that connects to an oxygen therapy flowmeter; and 2) one to which the patient tubing is connected. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTT	HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K945782	000

Device Exempt from Premarket Submission: No 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
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 22 Millimeter

Device Record Status

Public Device Record Key: 32e257e9-2cc4-4568-b60a-6264334b2ea0
Public Version Date: July 31, 2018
Public Version Number: 1
DI Record Publish Date: June 30, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(724)744-2500
Email: RESPIRONICS.SERVICE@PHILIPS.COM

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