FDA.reportPublic FDA data

Salter AIRE Elite

Primary DI
00607411915666
Brand
Salter AIRE Elite
Company
SALTER LABS
Model
SO-1931GN
Catalog number
SO-1931GN
Device description
Compressor with Nebulizer No. 8900
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
CCQNEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)Anesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K870027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K870027000HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZERSalter Labs1987-03-16CCQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607411915666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607411915666006074119156666074119156660607411915666

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
022721133
Device count
1
Kit
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00607411006067N/ASO-1613-0SO-1613-02016-09-24
00607411006319N/ASO-1635-0SO-1635-02016-09-24
00607411006593N/AE7600-0E7600-02018-03-12
00607411006715N/ASO-1658-0SO-1658-02016-09-24
00607411006722N/ASO-1352SO-13522016-09-24
00607411006814N/ASO-1343SO-13432016-09-24
00607411007408N/ASO-1738-0SO-1738-02016-09-24
00607411007576N/ASO-500-0SO-500-02016-09-24
00607411007644N/ASO-1756-0SO-1756-02016-09-24
00607411007781N/ASO-1767-0SO-1767-02016-09-24
00607411007798N/ASO-1768-0SO-1768-02016-09-24
00607411009235N/ASO-1662-0SO-1662-02016-09-24
00607411009273N/ASO-1667-0SO-1667-02016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704714480LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2026-07-29
14026704714497LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2026-07-29
14026704714503LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2026-07-27
04719874955663Create BiotechCREATE BIOTECH CO., LTD.CCQ2026-07-21
04719874955700Create BiotechCREATE BIOTECH CO., LTD.CCQ2026-07-21
14026704714510LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2026-07-21
00850022483387Dr. Noze Best NebulizerDr. Noze Best, LLCCCQ2026-05-26
00850079671010NavägeRhinosystems, Inc.CCQ2026-03-02
14026704714527LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2025-12-08
24026704714524LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2025-12-08
00850024829367Shusher CarePENO LLCCCQ2025-11-03
06945040113850CONTECContec Medical Systems Co., Ltd.CCQ2025-10-13
06945040110637CONTECContec Medical Systems Co., Ltd.CCQ2025-08-12
06973134772126silverfoxSilverfox Corporation LimitedCCQ2025-01-06
00840183528423BR Surgical, LLCBR Surgical, LLCCCQ2024-11-07
00628725098203VixOne™ Nebulizer Kit Canadian Hospital Specialties LimitedCCQ2024-08-20
50628725098208VixOne™ Nebulizer Kit Canadian Hospital Specialties LimitedCCQ2024-08-20
00851440007728Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00851440007735Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00851440007742Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007725Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007732Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007749Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00810094577179CuraplexBOUND TREE MEDICAL, LLCCCQ2024-07-30
00840183522018BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183524128BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183525255BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183526689BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
06971066425639FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06