FDA.reportPublic FDA data

NAMIC

Primary DI
10193489087789
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
70015433
Catalog number
70015433
Device description
MTS SC 4W LP 33 IV MLS OFF R PG
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
K790082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790082000ARTERIAL EXTENSION SETNamic1979-01-25DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489087789PackageGS125In Commercial Distribution
30193489087783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348908778910193489087789
3019348908778330193489087783

GMDN Terms#

Term, Definition table
TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Inch

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
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729188865Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200291Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213161Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213178Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213185Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213192Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213208Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213369Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213666Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213741Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213888Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213918Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214007Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214083Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214120Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214168Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214243Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214342Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214380Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214441Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214472Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214502Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214632Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214656Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214663Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24