FDA.reportPublic FDA data

ComfortGel

Primary DI
00606959015395
Brand
ComfortGel
Company
Lifeline Systems Company
Model
00
Catalog number
1070056
Published
2015-11-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092835000COMFORTGEL NASAL MASKRespironics Inc., Sleep & Home Respiratory Group2010-02-12BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00606959015395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00606959015395006069590153956069590153950606959015395

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity-20 Degrees Celsius60 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500respironics.service@philips.com

Regulatory Flags#

DUNS number
080030042
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838100046Senior Living Personal Help Device Pendant300005057751319PHB2021-04-29
00884838100053Senior Living Personal Help Device Wriststrap300005057731319PHW2021-04-29
00884838100060HomeSafe Standard Personal Help Pendant300005057791324PHB2021-04-29
00884838100077HomeSafe Standard Personal Help Wriststrap300005057771324PHW2021-04-29
00884838100008GoSafe / HomeSafe Personal Help Pendant3000048732617000PHB2021-04-02
00884838100015Senior Living Alert Device Personal Help Pendant with Indicator3000048733217000PHB-SL2021-04-02
00884838100022GoSafe / HomeSafe Personal Help Wriststrap3000048733317000PHW2021-04-02
00884838100039Senior Living Alert Device Personal Help Wriststrap with Indicator3000048733517000PHW-SL2021-04-02
00884838099968GoSafe / HomeSafe AutoAlert Pendant3000004911317000AHB2021-03-19
00884838099975Senior Living Alert Device AutoAlert with Indicator3000004911517000AHB-SL2021-03-19
00884838099982HomeSafe AutoAlert Pendant300000491111FD1002021-03-19
00884838099999Senior Living Alert Device AutoAlert300000491121FD100-SL2021-03-19
00884838093638Philips GoSafe 23000027063117250MHB2020-07-10
00884838091573Philips GoSafe 23000025669817150MHB2019-06-01
00884838091580Philips GoSafe3000025669717100MHB2019-06-01
00884838097551Philips BlueBand300004069001BBM01102020-01-01
00884838096776HomeSafe (Wireless) Home Communicator3000034728217200C2019-11-01
00884838094048HomeSafe Standard Home Communicator3000029856516903AT2019-07-02
00884838088597HomeSafe Standard Personal Help Pendant300001287651324PHB2019-05-16
00884838088603HomeSafe Standard Personal Help Wriststrap300001287661324PHW2019-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109066CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00814747024898Novaplus Pediatric Nasal Non Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024904Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024911Novaplus Pediatric Nasal Non Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024928Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00848530109097CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109264CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109271CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109288CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
04719893348873WellellWellell Inc.BZD2026-06-01
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