FDA.reportPublic FDA data

Nasal Oxygen Cannula

Primary DI
00850014433154
Brand
Nasal Oxygen Cannula
Company
DISTRIBUTION UNLIMITED, LLC
Model
1
Catalog number
DU1010
Device description
The nasal cannula is a device used to deliver supplemental oxygen or increased airflow to a patient or person in need of respiratory help.
Published
2020-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850014433158PackageGS1100In Commercial Distribution
00850014433154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085001443315820850014433158
00850014433154008500144331548500144331540850014433154

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration enhancement deviceA non-sterile device intended to be used to rapidly provide a supply of inhaled oxygen (O2) at higher than normal concentrations (e.g., FiO2 concentrations of 70% at 6L/min), typically for a patient during recovery [e.g., in the operating room (OR)]. It typically includes tubing that connects directly to an O2 source, a reservoir bag that concentrates the O2 and enables confirmation of respiration through its movement, a coupling that connects into an artificial airway already in situ, and a port for exhalation of gases. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Feet

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
926603486
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014433253Syringe 3ml w/o Needle1DU25032020-08-06
00850014433260Syringe 5ml w/o Needle1DU25052020-08-06
00850014433284Syringe 10ml w/o Needle1DU25102020-08-06
00850014433642Universal Block Procedure Trays1DU36402020-08-19
00850014433161Grounding Pads1DU21002020-08-13
00850014433130"IV Extension Set 6"" "1DU22602020-08-19
00850014433222"Tourniquet 1""x18"""1DU22102020-08-06
00850014433215ETCO2 Nasal Cannula1DU10902020-08-13
00850014433505"Cohesive bandage 2""x5yds stretched"1DU35502020-08-06
10850014433137IV Extension Set 6" 1DU22602020-08-19
20850014433646Universal Block Procedure Trays1DU36402020-08-19
00850014433239Sterile Specimen Cup with Temp Strip1DU31002020-08-13
10850014433168Grounding Pads1DU21002020-08-13
20850014433219ETCO2 Nasal Cannula1DU10902020-08-13
10850014433236Sterile Specimen Cup with Temp Strip1DU31002020-08-13
00850014433109Anesthesia Mask (Large) 1DU10782020-08-06
00850014433123Anesthesia Mask (Medium) 1DU10732020-08-06
00850014433178"Ice Compress 4""x7"""1DU17032020-08-06
00850014433246Non Woven Sponge 2x2 4 ply 1DU12022020-08-06
00850014433291"3ml Syringe w/ 18g x 1"" Needle"1DU25232020-08-06

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