FDA.reportPublic FDA data

Medline

Primary DI
10193489031799
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
PAINLOR7NRLS
Catalog number
PAINLOR7NRLS
Device description
SYR PLASTIC LOSS OF RESISTANCE 7CC NR LS
Published
2022-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201356000Plastic LOR SyringeJiangsu Caina Medical Co.,Ltd2021-02-12CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489031796PackageGS125In Commercial Distribution
10193489031799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348903179620193489031796
1019348903179910193489031799

GMDN Terms#

Term, Definition table
TermDefinition
Low-resistance epidural syringeA low-friction glass or plastic barrel (cylinder) with plunger intended to be used with a needle typically to locate the epidural space. The user advances the needle until a loss of resistance (LOR) is sensed in the plunger, indicating entry into the epidural space. The syringe may then be disconnected to allow the introduction of a catheter through the needle for diagnostic or therapeutic intervention. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196301904MedlineMDS10781MDS107812016-10-14
10080196301898MedlineMDS10780MDS107802016-10-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489490312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAZ2022-08-04
10193489031768MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031775MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031782MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10381780529071Integra®INTEGRA PAIN MANAGEMENTCAZ2019-10-24
10381780527633Integra®INTEGRA PAIN MANAGEMENTCAZ2019-07-16
10381780527404Integra®INTEGRA PAIN MANAGEMENTCAZ2019-05-13
10381780527015Integra®INTEGRA PAIN MANAGEMENTCAZ2019-03-05
10381780511465Integra®INTEGRA PAIN MANAGEMENTCAZ2019-02-27
10381780511281Integra®INTEGRA PAIN MANAGEMENTCAZ2019-01-18
10381780491316Integra®INTEGRA PAIN MANAGEMENTCAZ2018-08-16
10381780464792Integra®INTEGRA PAIN MANAGEMENTCAZ2018-07-16
10381780429531Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431640Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431657Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431749Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431763Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431770Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780466611Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780486756Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780486763Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780429487Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429494Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429524Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429562Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429586Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429593Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429609Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429616Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429623Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20