FDA.reportPublic FDA data

n/a

Primary DI
00607411007590
Brand
n/a
Company
SALTER LABS
Model
6500
Catalog number
6500
Device description
SPIROMETER KITDISPOSABLE (single patient use)
Published
2016-11-30
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
10607411007597PackageGS125In Commercial Distribution
20607411007594PackageGS150In Commercial Distribution
00607411007590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741100759710607411007597
2060741100759420607411007594
00607411007590006074110075906074110075900607411007590

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).

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411201509Salter Labs Adult, ETC02 Nasal Sampling Cannula, female luer style connecSO-165090122016-09-24
00607411001147AirLife1007-01007-0-102016-11-30
00607411001154AirLife1008-01008-0-102016-11-30
00607411001024AirLife1005-01005-0-252016-11-30
10607411001045AirLife1016-0-251016-0-252016-11-30
10607411891714AirLife1017-0-251017-0-252016-11-30
10607411001038AirLife1006-0-1001006-0-1002016-11-30
10607411891110AirLife1217-0-251217-0-252016-11-30
00607411001048AirLife1016-01016-02019-04-29
00607411919039Salter Labs® High Concentration partial rebreather131202026-06-10
00607411919077Salter Labs® Nasal Cannula133002026-06-10
00607411919091Salter Labs® Nasal Cannula133042026-06-10
00607411919121Salter Labs® Nasal Cannula133092026-06-10
00607411919190Salter Labs® Nasal Cannula133372026-06-10
00607411919213Salter Labs® Nasal Cannula133472026-06-10
00607411919268Salter Labs® Oxygen Tubing134092026-06-10
00607411919282Oxygen Tubing Swivel Connector134452026-06-10
00607411919336Salter Labs® Percent-O2-Lock® Mask138152026-06-10
00607411919343Salter Labs® Full Kit Nebulizer139502026-06-10
00607411919367Salter Labs® Full Kit Nebulizer Set139522026-06-10

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