FDA.reportPublic FDA data

N/A

Primary DI
00607411600036
Brand
N/A
Company
SALTER LABS
Model
6010-0-50
Catalog number
6010-0-50
Device description
Spirometer, mouthpiece connector, mouthpiece to respirometer connector - 25/cs
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSPIROMETER, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863656000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863656000SALTER VOLUCHEK 6600Salter Labs1986-10-06BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607411600036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607411600036006074116000366074116000360607411600036

GMDN Terms#

Term, Definition table
TermDefinition
Peak flow meter, manualA manual, hand-held instrument designed to measure only the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] from the lungs. It typically includes a tube for patient exhalation, an easy-to-grip handle, and a calibrated scale that shows the value of the peak flow. The device helps to discriminate the pulmonary status in routine tests performed in or outside of a clinical setting; it is also intended for periodic self-evaluation of the respiratory status of a patient, and to help in the treatment evaluation of patients suffering from chronic respiratory disorders (e.g., asthma, emphysema).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)421-0024customercare@salterlabs.com

Regulatory Flags#

DUNS number
022721133
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411890178N/A891289122016-09-24
00607411890185N/A891389132016-09-24
00607411890246N/A892389232016-09-24
00607411000881N/A5006-15006-12016-09-24
00607411917332Salter LabsOTC-101-7 (QTY 5)OTC-101-7 (QTY 5)2026-10-07
00607411917363Salter LabsOTC-102-4 (QTY 5)OTC-102-4 (QTY 5)2026-10-07
00607411917394Salter LabsOTC-102-7 (QTY 5)OTC-102-7 (QTY 5)2026-10-07
00607411000966AirLife7001-07001-02016-11-30
00607411001130AirLife1220-01220-02016-11-30
00607411001215AirLife1225-01225-02016-11-30
00607411888922N/AM5120-0M5120-02016-09-24
00607411917615n/aOTC-203-25 (QTY1)OTC-203-25 (QTY1)2016-11-30
00607411917646n/aOTC-203-50 (QTY1)OTC-203-50 (QTY1)2016-11-30
00607411918346Salter AIRE EliteSO-1774BESO-1774BE2016-09-24
00607411400711N/ASO-431SO-4312016-09-24
10607411920117N/AM123138-0M123138-02016-09-24
00607411000409N/ASO-1394SO-13942016-09-24
00607411000461N/ASO-1392-0SO-1392-02016-09-24
00607411000478N/ASO-1393SO-13932016-09-24
00607411005756N/ASO-1608-0SO-1608-02016-09-24

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Primary DI, Brand, Company table
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