FDA.report

Portex

Primary DI
35019315043929
Brand
Portex
Company
SMITHS MEDICAL ASD, INC.
Model
Z130-14
Published
2016-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Product Code Classifications

CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
35019315043929PackageGS120In Commercial Distribution
15019315043925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3501931504392935019315043929
1501931504392515019315043925

GMDN Terms

TermDefinition
Tracheobronchial suction/insufflation catheter, single-lumenA sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a single lumen tube for alternating suction and insufflation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
137835299
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
Sterilization required before use
false

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