FDA.reportPublic FDA data

N/A

Primary DI
10607411889346
Brand
N/A
Company
SALTER LABS
Model
SO-1818-0
Catalog number
SO-1818-0
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411889346PackageGS125In Commercial Distribution
00607411889349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741188934610607411889346
00607411889349006074118893496074118893490607411889349

GMDN Terms#

Term, Definition table
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.

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
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

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Primary DI, Brand, Model table
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10607411007344Sticky WhiskersSW102-0-25SW102-0-252016-09-24
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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

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