FDA.report

Portex

Primary DI
50788942201208
Brand
Portex
Company
SMITHS MEDICAL ASD, INC.
Model
20-0120
Published
2016-10-11
Public version status
Update
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

Product Codes

CodeName
BWFSPIROMETER, THERAPEUTIC (INCENTIVE)

Product Code Classifications

CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50788942201208PackageGS110In Commercial Distribution
10788942201200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5078894220120850788942201208
1078894220120010788942201200

GMDN Terms

TermDefinition
Incentive spirometerA hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
828611934
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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