FDA.reportPublic FDA data

N/A

Primary DI
00607411001352
Brand
N/A
Company
SALTER LABS
Model
1302-0-10
Catalog number
1302-0-10
Device description
PEP, kit w/manometer - 10/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
CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991788000SALTER LABS PEP DEVICESalter Labs1999-08-06CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411001359PackageGS125In Commercial Distribution
00607411001352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741100135910607411001359
00607411001352006074110013526074110013520607411001352

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic agent nebulizer, benchtopAn assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10888277657625MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699205MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699229MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699236MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.CAF2021-10-01
00888277692100MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-05-18
00888277699215MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-05-18