FDA.reportPublic FDA data

N/A

Primary DI
00607411302107
Brand
N/A
Company
SALTER LABS
Model
M842611PB
Catalog number
M842611PB
Device description
Aerosol Tee Adaptor
Published
2016-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10607411302104PackageGS150In Commercial Distribution
00607411302107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741130210410607411302104
00607411302107006074113021076074113021070607411302107

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
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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