FDA.reportPublic FDA data

Medline

Primary DI
40884389967301
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
HCS00550
Catalog number
HCS00550
Device description
HUMIDIFIER,PREFILLED,550ML,H2O,STRL
Published
2021-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389967301PackageGS112In Commercial Distribution
10884389967300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438996730140884389967301
1088438996730010884389967300

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation therapy sterile waterA quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume550Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884389177686MEDLINEMDSMPHS4MDSMPHS42021-04-23
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19

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Primary DI, Brand, Company table
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09420012430410Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012449818Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012465849Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-03-18
09420012471918Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-03-18
09420012481740F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481795F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481818F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
10197344005994HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-02
10197344009725HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
10197344009596HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-17
10197344029693HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-14
10197344029730HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-14
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10197344009879HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
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10197344029723HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344009589HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344009848HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344011025HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344011056HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344009817HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-04-05
10197344009831HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-03-24
10193489149296HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-11-22