FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942722396
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
SAMPC0289
Catalog number
SAMPC0289
Device description
CSTM MANIFOLD KIT - PARIS
Published
2018-08-28
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
DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889942722396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088994272239610889942722396

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716102704ACIST VeraPro HiFi 165ACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102728ACIST VeraPro FLX 165ACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102742ACIST VeraPro S100 Multi-Use SyringeACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102773ACIST VeraPro S100 LV1 Low-Viscosity SyringeACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
10841716102803ACIST VeraPro AMT Auto-Manifold and TransducerACIST MEDICAL SYSTEMS, INC.DXT2026-05-26
00884450435533Merit Medical®Merit Medical Systems, Inc.DXT2026-05-23
10884450121433Merit Medical®Merit Medical Systems, Inc.DXT2026-01-13
00616258020419MEDRAD® Mark 7 Arterion Injection SystemBayer Medical Care Inc.DXT2025-12-19
40616258021247MEDRAD® VFLOW Sterile Disposable Hand ControllerBayer Medical Care Inc.DXT2025-12-19
00616258025186MEDRAD® Stellant CT Injection SystemBayer Medical Care Inc.DXT2025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc.DXT2025-12-10
49345390003538MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
26938327901909DeRoyalShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-28
26938327909189Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909199Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
16938327909205Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2025-11-17
26945764400148AntmedShenZhen Antmed Co., LtdDXT2025-09-17
26945764400162AntmedShenZhen Antmed Co., LtdDXT2025-09-17
50628725095078MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095085MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095108MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095160MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095177MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095184MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095191MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
50628725095214MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-09-11
09345390003356MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-08-18
00628725095066MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095153MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15
50628725095207MISI-Medical Imaging Solutions InternationalCanadian Hospital Specialties LimitedDXT2025-08-15