FDA.reportPublic FDA data

NAMIC

Primary DI
20193489069508
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
92051483
Catalog number
92051483
Device description
CIL FLEX HP 48 FLL-RA W/DRAPE CLIP
Published
2021-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822100000HIGH PRESSURE CONTRAST INJECTION LINENamic1982-08-24DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489069508PackageGS125In Commercial Distribution
10193489069501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348906950820193489069508
1019348906950110193489069501

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic procedure tubingA flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length48Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
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
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
10080196456765MEDLINEVDYND20302VDYND203022026-07-14
10080196031764MEDLINEDYND20125DYND201252026-07-13
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10197344176007MEDLINEESS9022EPESS9022EP2026-07-13
10197344176014MEDLINEESS9045EPESS9045EP2026-07-13
10197344176021MEDLINEESS9048EPESS9048EP2026-07-13
10197344176038MEDLINEESS9066EPESS9066EP2026-07-13
10197344214723MEDLINEHCSLADYBUGSOLHCSLADYBUGSOL2026-07-13
20193489108214MEDLINEMDTZ1017073CAMDTZ1017073CA2026-07-13
20197344219435MEDLINEMDT2168056XGVMDT2168056XGV2026-07-13
20888277636559MEDLINEMDTZ1017073ABMDTZ1017073AB2026-07-13
10080196316809MedlineMSC8722EPMSC8722EP2023-08-15
10080196316816MedlineMSC8744EPMSC8744EP2023-08-15
10193489081053MedlineMSC8422MSC84222023-08-15
10193489081060MedlineMSC8444MSC84442023-08-15
10197344039821MEDLINEHNY19075HNY190752024-10-11
10884389122952MedlineMSC871X8EPMSC871X8EP2023-08-15
10884389155448MedlineMSC8488MSC84882023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156112035LANGSTONTELEFLEX INCORPORATEDDQO2026-06-26
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
07290017268316SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268323SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268330SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268361SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268385SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268392SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268408SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268804DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268811DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268828DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268866DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268873DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268880DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268309SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268835DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268842DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268859DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
07290017268002SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268019SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268026SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268033SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10