FDA.reportPublic FDA data

n/a

Primary DI
00607411007583
Brand
n/a
Company
SALTER LABS
Model
6400
Catalog number
6400
Device description
DISPOSABLE SPIROMETER 10 Liter Calibrated Collection Bag DISPOSABLE (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
10607411007580PackageGS125In Commercial Distribution
00607411007583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741100758010607411007580
00607411007583006074110075836074110075830607411007583

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
00607411946684Salter Labs47SOFT-TG-14-1447SOFT-TG-14-142026-08-03
00607411961342N/A4707TG-7-74707TG-7-72026-08-03
00607411400049N/A4002-7-74002-7-72016-09-24
00607411400056N/A4002F-7-74002F-7-72016-09-24
00607411400162N/A4101-7-74102-7-72016-09-24
00607411400940N/A4796F-7-04796F-7-02016-09-24
00607411400957N/A4797-7-74797-7-72016-09-24
00607411400964N/A4797F-7-74797F-7-72016-09-24
00607411401015N/A4793-7-74793-7-72016-09-24
00607411401039N/A4793F-7-74793F-7-72016-09-24
00607411801211N/A4102F-7-74102F-7-72016-09-24
00607411918421N/A4002-14-144002-14-142016-09-24
00607411947360N/A4797TG-7-74797TG-7-72017-10-26
00607411947124N/A49SOFT-TG-10-1049SOFT-TG-10-102026-07-28
00607411947131N/A49SOFT-TG-14-1449SOFT-TG-14-142026-07-28
00607411947162N/A49SOFT-F-14-1449SOFT-F-14-142026-07-28
00607411000263N/A4702F-7-04702F-7-02016-09-24
00607411000270N/A4703F-7-74703F-7-72016-09-24
00607411400391N/A4700-7-74700-7-72016-09-24
00607411400407N/A4700F-7-74700F-7-72016-09-24

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