FDA.reportPublic FDA data

n/a

Primary DI
10607411007566
Brand
n/a
Company
SALTER LABS
Model
6002
Catalog number
6002
Device description
SPIROMETER Manometer Connecting Pressure Cap with 14" Tubing and Relief Port 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
OTC
false
Sterile
false
Single use
false

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
10607411007566PackageGS150In Commercial Distribution
00607411007569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741100756610607411007566
00607411007569006074110075696074110075690607411007569

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607411007146CannulaideCA100-0-25CA100-0-252016-09-24
10607411007153CannulaideCA101-0-25CA101-0-252016-09-24
10607411007160CannulaideCA102-0-25CA102-0-252016-09-24
10607411007177CannulaideCA103-0-25CA103-0-252016-09-24
10607411007184CannulaideCA104-0-25CA104-0-252016-09-24
00607411301681N/A4950-7-74950-7-72016-09-24
00607411301698N/A4950F-7-74950F-7-72016-09-24
00607411301711N/A4950F-7-04950F-7-02016-09-24
00607411301728N/A4950-10-104950-10-102016-09-24
00607411301735N/A4950-14-144950-14-142016-09-24
00607411301742N/A4950F-14-144950F-14-142016-09-24
00607411301759N/A4950F-10-104950F-10-102016-09-24
00607411401367N/A49SOFT-FTG-10-1049SOFT-FTG-10-102017-11-21
00607411945397N/A49SOFT-7-7-049SOFT-7-7-02017-07-28
00607411945755N/A4950FTG-7-74950FTG-7-72017-07-28
00607411945816N/A49SOFT-14-1449SOFT-14-142017-08-28
00607411945823N/A49SOFT-F-7-749SOFT-F-7-72017-08-28
00607411947155N/A49SOFT-FTG-7-749SOFT-FTG-7-72017-11-21
00607411919145N/A4950TG-7-74950TG-7-72017-05-12
00607411919169N/A4950TG-14-144950TG-14-142017-05-12

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