FDA.reportPublic FDA data

NEXTGEN

Primary DI
00850050764335
Brand
NEXTGEN
Company
Nextgen Medical Supplies LLC
Model
CT-CNC01
Published
2023-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00850050764342PrimaryGS10
00850050764335Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050764342008500507643428500507643420850050764342
00850050764335008500507643358500507643350850050764335

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, carbon-dioxide-samplingA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125283823
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050764304Disposable IV CatheterIVC09-242023-07-01
00850050764342NEXTGENCT-CNC012023-07-01
00850050764328Disposable IV CatheterIVC09-242023-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118600361Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118607988Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118609616Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118614900Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617338Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617352Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617376Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617390Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617413Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617437Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617895Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620901Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620918Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620925Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118620932Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118621052Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
04719874951023Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-21
04719874952471Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-21
04719874950682Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950699Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950705Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950712Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950729Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874950736Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874951306Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874951313Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952419Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952426Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952433Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20
04719874952464Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-20