FDA.reportPublic FDA data

Endure Industries

Primary DI
00840118620925
Brand
Endure Industries
Company
ENDURE INDUSTRIES
Model
CLM7
Catalog number
CLM7
Device description
SELONTA ETCO2 | 7ft | Male | Std Connector | Cloud
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
00840118620963PackageGS140In Commercial Distribution
00840118623063PackageGS1160In Commercial Distribution
00840118620925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118620963008401186209638401186209630840118620963
00840118623063008401186230638401186230630840118623063
00840118620925008401186209258401186209250840118620925

GMDN Terms#

Term, Definition table
TermDefinition
Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to predict or monitor the genetic predisposition of a patient exhibiting resistance to anticoagulation agents based on multiple genetic markers which may include the Cytochrome P450 superfamily (CYP450) and Vitamin K epoxide reductase complex subunit-1 (VKORC1) gene polymorphisms, using a nucleic acid technique (NAT). It is used to aid therapy management of patients with thromboembolic disease typically treated with coumarin derivatives (e.g., warfarin).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
6072994971support@endureind.com

Regulatory Flags#

DUNS number
066087031
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
true
Expiration date on label
true
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
00840118621137Endure IndustriesOMEP11OMEP112026-08-17
00840118600361Endure IndustriesNDAFC211NDAFC2112026-08-14
00840118602150Endure IndustriesECAKCDQ-118ECAKCDQ-1182026-08-14
00840118607988Endure IndustriesNCAC211NCAC2112026-08-14
00840118609616Endure IndustriesNDAMC211NDAMC2112026-08-14
00840118614245Endure IndustriesESP38ESP382026-08-14
00840118614252Endure IndustriesESP310ESP3102026-08-14
00840118614269Endure IndustriesESP511ESP5112026-08-14
00840118614276Endure IndustriesESP516ESP5162026-08-14
00840118614283Endure IndustriesESP713ESP7132026-08-14
00840118614290Endure IndustriesESP916ESP9162026-08-14
00840118614306Endure IndustriesESP1118ESP11182026-08-14
00840118614900Endure IndustriesNDAF211NDAF2112026-08-14
00840118616447Endure IndustriesEBSEBS2026-08-14
00840118617338Endure IndustriesNDAM411UNDAM411U2026-08-14
00840118617352Endure IndustriesNDAM411NDAM4112026-08-14
00840118617376Endure IndustriesNDAF411UNDAF411U2026-08-14
00840118617390Endure IndustriesNDAF411NDAF4112026-08-14
00840118617413Endure IndustriesNCPC211NCPC2112026-08-14
00840118617437Endure IndustriesNDPM211NDPM2112026-08-14

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
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
04719874950293Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-19