AcuCare 60980

GUDID 00619498609802

NV AcuCare F1-0 FFM SML - 5pk

RESMED LIMITED

Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask Rebreathing oxygen face mask CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable
Primary Device ID00619498609802
NIH Device Record Key0586ce54-50ed-466f-8be9-08b011ee93c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcuCare
Version Model NumberF1-0
Catalog Number60980
Company DUNS751149311
Company NameRESMED LIMITED
Device Count5
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com
Phone800-424-0737
Emailreception@resmed.com

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100619498609802 [Primary]
GS110619498607508 [Unit of Use]

FDA Product Code

BSJMask, Gas, Anesthetic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-23
Device Publish Date2017-02-10

On-Brand Devices [AcuCare]

00619498609888AcuCare F1-4 FFM LGE - USA 5pk
00619498609871AcuCare F1-4 FFM MED - 5pk
00619498609864AcuCare F1-4 FFM SML - 5pk
00619498609857NV AcuCare F1-1 FFM LGE - 5pk
00619498609840NV AcuCare F1-1 FFM MED- 5pk
00619498609833NV AcuCare F1-1 FFM SML - 5pk
00619498609826NV AcuCare F1-0 FFM LGE 5pk
00619498609819NV AcuCare F1-0 FFM Med - 5 pk
00619498609802NV AcuCare F1-0 FFM SML - 5pk
00619498607587AcuCare F1-4 FFM LGE-USA 20pk
00619498607570AcuCare F1-4 FFM MED-USA 20pk
00619498607563AcuCare F1-4 FFM SML-USA 20pk
00619498607556NV AcuCare F1-1 FFM LGE-USA 20pk
00619498607549NV AcuCare F1-1 FFM MED-USA 20pk
00619498607532NV AcuCare F1-1 FFM SML-USA 20pk
00619498607525NV AcuCare F1-0 FFM LGE-USA 20pk
00619498607518NV AcuCare F1-0 FFM MED-USA 20pk
00619498607501NV AcuCare F1-0 FFM SML-USA 20pk
00619498607174ACUCARE F1-4 FFM LGE
00619498607167ACUCARE F1-4 FFM MED
00619498607150ACUCARE F1-4 FFM SML
00619498607143NV ACUCARE F1-1 FFM LGE
00619498607136NV ACUCARE F1-1 FFM MED
00619498607129NV ACUCARE F1-1 FFM SML
00619498607082NV ACUCARE F1-0 FFM LGE
00619498607075NV ACUCARE F1-0 FFM MED
00619498607068NV ACUCARE F1-0 FFM SML
00619498607914NV AcuCare F1-1 FFM LGE - 5pk
00619498607907NV AcuCare F1-1 FFM MED- 5pk
00619498607891NV AcuCare F1-1 FFM SML - 5pk
00619498607884NV AcuCare F1-0 FFM LGE 5pk
00619498607877NV AcuCare F1-0 FFM Med - 5 pk
00619498607860NV AcuCare F1-0 FFM SML - 5pk

Trademark Results [AcuCare]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACUCARE
ACUCARE
90221935 not registered Live/Pending
2283269 ALBERTA LTD.
2020-09-29
ACUCARE
ACUCARE
86373547 4784614 Live/Registered
RESMED PTY LTD
2014-08-21
ACUCARE
ACUCARE
78622868 not registered Dead/Abandoned
IntraLens Vision, Inc.
2005-05-04
ACUCARE
ACUCARE
78142248 2788746 Dead/Cancelled
ALTERITECH, INC.
2002-07-09
ACUCARE
ACUCARE
73687444 1487384 Dead/Cancelled
RICHARDSON-VICKS INC.
1987-10-01
ACUCARE
ACUCARE
73463806 1310515 Dead/Cancelled
Acucare, Inc.
1984-02-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.