FDA.report

N/A

Primary DI
10607411920063
Brand
N/A
Company
SALTER LABS
Model
SO-663-0
Catalog number
SO-663-0
Device description
PATIENT KIT
Published
2016-09-24
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

Related Records

Contact Domains

Product Codes

CodeName
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Product Code Classifications

CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10607411920063PackageGS110In Commercial Distribution
00607411920066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741192006310607411920063
00607411920066006074119200666074119200660607411920066

GMDN Terms

TermDefinition
Non-heated respiratory humidifierA device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (reservoir) for the water, a top piece that functions as a detachable lid (typically a screw lid with a gastight seal), and a tube that protrudes into the water to divert the gas below the water level. This device, commonly known as a bubble humidifier, does not heat the water. It has connectors: 1) one (e.g., a winged nut) that connects to an oxygen therapy flowmeter; and 2) one to which the patient tubing is connected. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)421-0024customercare@salterlabs.com

Regulatory Flags

DUNS number
022721133
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
20889483224363MVAP Comfort Sleep Nasal CannulaHST332026-03-13
20889483225292MVAP Comfort Sleep Nasal CannulaSDC842026-03-13
20889483226435Bell Medical CannulaB180032C2026-03-13
10607411007344Sticky WhiskersSW102-0-25SW102-0-252016-09-24
10607411950503AirLife™2001-12001-12026-01-19
30889483236325Iradimed Adult Capnography Cannula1842A2025-08-04
30889483236332Iradimed Infant Capnography Cannula1842I2025-08-04
30889483236349Iradimed Pediatric Capnography Cannula1842P2025-08-04
30889483236356Iradimed1843A2025-08-04
30889483236363Iradimed1843P2025-08-04
30889483236370Iradimed1844A2025-08-04
30889483236387Iradimed1844P2025-08-04
30889483236318Iradimed Sample Line Extension18412025-08-04
30889483610569Resmed Sleep Apnealink Cannula707103162025-07-11
20889483569990O2 Cannula001321U2024-12-31
20889483570019O2 Cannula001322U2024-12-31
20889483570040O2 Cannula001326U2024-12-31
20889483570156O2 Cannula0013652024-12-31
20889483571375O2 Cannula002600-25U2024-12-31
20889483571504O2 Cannula0026922024-12-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
64897132250476TECMEVINCENT HEALTHCARE PRODUCTS LIMITEDBTT2026-03-17
64897132250315inspired™VINCENT HEALTHCARE PRODUCTS LIMITEDBTT2026-03-05
30889483631472AirLifeSUNMED, LLCBTT2026-02-27
09420012481757F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481801F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481825F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
10197344007165HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-03
20197344005991HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-02
20197344009722HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
10889483648162AirLife™AIRLIFEBTT2026-01-14
20197344009821HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009852HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009869HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009876HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029706HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029713HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344029720HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
20197344009586HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344009845HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344011022HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
20197344011053HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
54026704734097HUDSON RCITELEFLEX INCORPORATEDBTT2025-06-04
54026704734103HUDSON RCITELEFLEX INCORPORATEDBTT2025-06-04
07321820069774Vivo 1/2, Vivo 3Breas Medical ABBTT2025-05-19
10889483631416AirLife™AIRLIFEBTT2025-04-21
10889483631423AirLife™AIRLIFEBTT2025-04-21
10889483631430AirLife™AIRLIFEBTT2025-04-21
10889483631447AirLife™AIRLIFEBTT2025-04-21
10889483631454AirLife™AIRLIFEBTT2025-04-21
10889483631461AirLife™AIRLIFEBTT2025-04-21