FDA.reportPublic FDA data

"Humidifier Tubing Connector with Tube 21"" "

Primary DI
00848530086251
Brand
"Humidifier Tubing Connector with Tube 21"" "
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
HUM008L
Catalog number
HUM008L
Device description
"Humidifier Tubing Connector with Tube 21"" "
Published
2018-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530086258PackageGS110In Commercial Distribution
20848530086255PackageGS120In Commercial Distribution
00848530086251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853008625810848530086258
2084853008625520848530086255
00848530086251008485300862518485300862510848530086251

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation-therapy adaptor, reusableA small connecting device, usually with a small channel, intended to join a sterile water pack or a sterile isotonic sodium chloride solution pack to an inhalation therapy device (e.g., humidifier, nebulizer, oxygen therapy delivery system) when the connection is not compatible (e.g., when the humidifier and the sterile water pack are of different manufacture). This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
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00848530109080CPAP HeadgearHG2062026-06-04
00848530109103CPAP HeadgearHG2072026-06-04
00848530108328Repair PartsRP0932026-06-03
00848530109097CPAP MaskCM060S2026-06-03
00848530109264CPAP MaskCM060M2026-06-03
00848530109271CPAP MaskCM060L2026-06-03
00848530109288CPAP MaskCM060XL2026-06-03
00848530108953Repair PartsRP1082026-06-02
00848530108960Repair PartsRP1092026-06-02
00848530108977Repair PartsRP1102026-06-02
00848530109011Repair PartsRP1112026-06-02
00848530109028Repair PartsRP1122026-06-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00607411919237Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
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00607411919251Salter Labs® Oxygen Tubing (MedTronic)SALTER LABSBYX2026-06-09
B929C4NI024FNNFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4AIK240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4OXW240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
00848530108328Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-03
00848530108953Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108960Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108977Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109011Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109028Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109035Repair PartSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109073Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
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