FDA.reportPublic FDA data

N/A

Primary DI
00607411700002
Brand
N/A
Company
SALTER LABS
Model
7100-0
Catalog number
7100-0
Device description
Bubble Humidifier with 3 PSI safety valve
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
10607411700009PackageGS150In Commercial Distribution
00607411700002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741170000910607411700009
00607411700002006074117000026074117000020607411700002

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
022721133
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00607411006814N/ASO-1343SO-13432016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24
00607411102738N/A7914-147914-142016-12-22
00607411300059N/ASO-388-0SO-388-02016-09-24
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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