FDA.reportPublic FDA data

NAMIC

Primary DI
20193489041436
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
60022053
Catalog number
60022053
Device description
MTO ANGIO KIT PALMETTO HLTH BPTST COLUMB
Published
2021-10-28
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489041436PackageGS110In Commercial Distribution
10193489041439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348904143620193489041436
1019348904143910193489041439

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

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
true
Premarket exempt
true
HCT/P
false
Kit
true
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
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
10809160521816HalyardAVID MEDICAL, INC.OEZ2026-05-26
10809160521823HalyardAVID MEDICAL, INC.OEZ2026-05-26
10198956359949CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956377790CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956382701CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956439337CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956442405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956443716CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956453203CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956459359CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956466333CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956470170CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956480582CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956480827CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956481770CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484153CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484405CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956484610CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956485211CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956486829CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956486867CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956487864CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488113CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488199CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488335CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488694CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956488731CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956489554CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
10198956490413CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-05-25
00884450437049Merit Medical®Merit Medical Systems, Inc.OEZ2026-05-23