Actical 1081737

GUDID 00606959021006

Actical

Respironics, Inc.

Kinesiology ambulatory recorder
Primary Device ID00606959021006
NIH Device Record Key8c521f9c-967d-4bc3-b5c0-00f2de55ed70
Commercial Distribution StatusIn Commercial Distribution
Brand NameActical
Version Model NumberACTICAL
Catalog Number1081737
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
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

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959021006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWKCONDITIONER, SIGNAL, PHYSIOLOGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2016-09-19

Devices Manufactured by Respironics, Inc.

00606959051942 - Trilogy Evo2022-05-23 Trilogy Evo, USA
00606959417540 - DreamStation2022-01-10 Micro-Flexible Heated 12mm Tube
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

Trademark Results [Actical]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACTICAL
ACTICAL
78105299 2745175 Live/Registered
RESPIRONICS, INC.
2002-01-28
ACTICAL
ACTICAL
76205881 not registered Dead/Abandoned
ADVANCED NUTRITIONAL PRODUCTS
2001-02-05

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