FDA.report

Humidifier Tubing Connector with Tube 21"

Primary DI
20848530086255
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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10848530086258PackageGS110In Commercial Distribution
20848530086255PackageGS120In Commercial Distribution
00848530086251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853008625810848530086258
2084853008625520848530086255
00848530086251008485300862518485300862510848530086251

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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