FDA.report

HUDSON RCI

Primary DI
20193489149668
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD1424
Catalog number
HUD1424
Device description
ADAPTER,OXYGEN,SWIVEL,MALE/MALE
Published
2024-05-09
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
BYXTUBING, PRESSURE AND ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489149668PackageGS120In Commercial Distribution
10193489149661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348914966820193489149668
1019348914966110193489149661

GMDN Terms

TermDefinition
Inhalation-therapy adaptor, single-useA connecting device, usually with a small channel or tubing, intended to join a water/saline pack or a noninvasive ventilation respiratory unit to an inhalation therapy device (e.g., humidifier, vibrating mesh nebulizer, oxygen therapy delivery system). It may be used when the connection is compatible (e.g., when the connected devices are of the same manufacture) or when incompatible (e.g., different manufacture). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry. Keep away from sunlight.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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