Replacement Part 24 Inch Grey Tubing 1006833

GUDID 00606959015210

Replacement Part 24 Inch Grey Tubing

Respironics, Inc.

Non-heated respiratory humidifier Non-heated respiratory humidifier
Primary Device ID00606959015210
NIH Device Record Key32e257e9-2cc4-4568-b60a-6264334b2ea0
Commercial Distribution StatusIn Commercial Distribution
Brand NameReplacement Part 24 Inch Grey Tubing
Version Model Number00
Catalog Number1006833
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(724)744-2500
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)744-2500
EmailRESPIRONICS.SERVICE@PHILIPS.COM

Device Dimensions

Outer Diameter22 Millimeter
Outer Diameter22 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959015210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-31
Device Publish Date2018-06-30

Devices Manufactured by Respironics, Inc.

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00606959060135 - Therapy Mask 31002021-12-16 Medium Wide, Therapy Mask 3100 Silicone
00606959060098 - Therapy Mask 31002021-11-04
00606959060104 - Therapy Mask 31002021-11-04
00606959060128 - Therapy Mask 31002021-11-04
00606959063082 - DreamStation 22021-11-04
00606959063228 - DreamStation 22021-11-04

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