FDA.reportPublic FDA data

GoodKnight

Primary DI
03700659400271
Brand
GoodKnight
Company
SEFAM
Model
GoodKnight 420E
Catalog number
M-113902
Device description
GoodKnight 420E is a sleep apnea therapy device with auto-adjustable algorithm (A-PAP device)
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700659400271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700659400271037006594002713700659400271

GMDN Terms#

Term, Definition table
TermDefinition
Home CPAP unitA portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.

Regulatory Flags#

DUNS number
262411625
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700659400257GoodKnightGoodKnight 420GM-1139002016-10-10
03700659400264GoodKnightGoodKnight 420SM-1139032016-10-10
03700659400301GoodKnightGoodKnight H2OM-1146002016-10-10
03700659400615BreezeBreeze PillowsM-268090-302016-10-19
03700659400622BreezeBreeze Nasal Comfort LM-268040-122016-10-19
03700659400639BreezeBreeze Nasal Comfort MM-268030-122016-10-19
03700659400646BreezeBreeze Nasal Comfort SM-268020-122016-10-19
03700659400653BreezeBreeze Nasal LM-268040-102016-10-19
03700659400660BreezeBreeze Nasal MM-268030-102016-10-19
03700659400677BreezeBreeze Nasal SM-268020-102016-10-19
03700659400684BreezeBreeze Nasal+ LM-268040-112016-10-19
03700659400691BreezeBreeze Nasal+ MM-268030-112016-10-19
03700659400707BreezeBreeze Nasal+ SM-268020-112016-10-19
03700659400714BreezeBreeze Facial Comfort LM-268040-212016-10-19
03700659400721BreezeBreeze Facial Comfort MM-268030-212016-10-19
03700659400738BreezeBreeze Facial Comfort SM-268020-212016-10-19
03700659400745BreezeBreeze Facial+ LM-268040-202016-10-19
03700659400752BreezeBreeze Facial+ MM-268030-202016-10-19
03700659400769BreezeBreeze Facial+ SM-268020-202016-10-19

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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