FDA.reportPublic FDA data

N/A

Primary DI
00607411006814
Brand
N/A
Company
SALTER LABS
Model
SO-1343
Catalog number
SO-1343
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)
OGGHumidifier Nebulizer Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2
OGGHumidifier Nebulizer KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411006811PackageGS110In Commercial Distribution
00607411006814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741100681110607411006811
00607411006814006074110068146074110068140607411006814

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411000737N/A8900-148900-142016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24
00607411102738N/A7914-147914-142016-12-22
00607411300059N/ASO-388-0SO-388-02016-09-24
00607411700002N/A7100-07100-02016-09-24
00607411700040N/A7600-07600-02016-09-24
00607411700057N/A7900-07900-02016-09-24
00607411889349N/ASO-1818-0SO-1818-02016-09-24
00607411889912n/aSO-1840-0SO-1840-02016-11-30
00607411890031N/A8900-78900-72016-09-24
00607411890055N/A8900TG-78900TG-72016-09-24
00607411890062N/A8901-08901-02016-09-24
00607411890079N/A8902-78902-72016-09-24
00607411890116N/A8905-08905-02016-09-24
00607411890123N/A8906-78906-72016-09-24
00607411890147n/a8910-08910-02016-11-30
00607411890154N/A8911-78911-72016-09-24
00607411890253N/A8924-78924-72016-09-24
00607411890260N/A8924TG-78924TG-72016-09-24
00607411890352NebuTech®8660-78660-72016-09-24

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