FDA.report

PORTEX

Primary DI
35019517128295
Brand
PORTEX
Company
Smiths Medical ASD, Inc.
Model
27-8050
Published
2021-04-07
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
false

Related Records

Product Codes

CodeName
BWFSPIROMETER, THERAPEUTIC (INCENTIVE)

Product Code Classifications

CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
35019517128295PackageGS150In Commercial Distribution
15019517128291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3501951712829535019517128295
1501951712829115019517128291

GMDN Terms

TermDefinition
Mechanical positive pressure airway secretion-clearing deviceA hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease. A positive expiratory pressure (PEP) is created when a patient exhales into the device, typically causing a high-density stainless steel ball to rapidly fluctuate up and down to create vibrations in the chest wall which loosens the mucus for expectoration and also assists in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
082005361
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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