FDA.reportPublic FDA data

TRI-BALL

Primary DI
18436020761833
Brand
TRI-BALL
Company
LEVENTON SAU
Model
L25912000
Device description
Respiratory Exerciser
Published
2017-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BWFSpirometer, Therapeutic (Incentive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994074000TRI-BALLLeventon, S.A.2000-06-08BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18436020761833PackageGS112In Commercial Distribution
08436020761836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843602076183318436020761833
08436020761836084360207618368436020761836

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
461437429
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436020761836TRI-BALLL259120002017-06-12
08436020761843SPIRO-BALLL259130002017-06-12
18436020761840SPIRO-BALLL259130002017-06-12
08436020769153DOSI-FLOWL2590260-US2023-09-08
08436020769160DOSI-FLOWL2590260-NF-US2023-09-08
08436020769177DOSI-FLOWL2590263S-SL-US2023-09-08
08436020769184DOSI-FLOWL2590263S-SL-NF-US2023-09-08
18436020769150DOSI-FLOWL2590260-US2023-09-08
18436020769167DOSI-FLOWL2590260-NF-US2023-09-08
18436020769174DOSI-FLOWL2590263S-SL-US2023-09-08
18436020769181DOSI-FLOWL2590263S-SL-NF-US2023-09-08
08436020768828DOSI-FLOWL2590252MS-MEG2023-08-10
08436020768835DOSI-FLOWL2590253S-FP-MEG2023-08-10
08436020769207DOSI-FLOWL2590253-MEG2023-08-10
08436020760099DOSI-FLOWL2590000502016-11-30
08436020760563DOSI-FLOWL2590000972016-11-30
08436020760914DOSI-FLOWL2590001502016-11-30
08436020761362DOSI-FLOWL2590253-VICTUS2016-11-30
08436020761706DOSI-FLOWL2590263-VICTUS2016-11-30
08436020763465DOSI-FLOWL2590003302016-11-30

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00851232007158OxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETERD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007585PocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPIECED R BURTON HEALTHCARE, LLCBWF2026-04-28
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