FDA.report

HUDSON RCI

Primary DI
34026704627692
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049120
Catalog number
006-40
Device description
AQUAPAK Sterile Water for Inhalation 650 mL w/ 040 Humidifier Adaptor
Published
2018-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OGGHumidifier nebulizer kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGGHumidifier Nebulizer KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704627692PackageGS110In Commercial Distribution
04026704597093PreviousGS10
14026704627698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670462769234026704627692
04026704597093040267045970934026704597093
1402670462769814026704627698

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00store at room temperature

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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