FDA.reportPublic FDA data

Halyard

Primary DI
10809160536711
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
MAMC217-22_0009
Catalog number
MAMC217-22
Published
2026-09-18
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

Product Codes#

Code, Name table
CodeName
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160536718PackageGS13In Commercial Distribution
10809160536711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053671820809160536718
1080916053671110809160536711

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Regulatory Flags#

DUNS number
015623119
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160536308HalyardVASF101-10_0001VASF101-102026-09-18
10809160536315HalyardVCIH001-03_0001VCIH001-032026-09-18
10809160536322HalyardVASF100-09_0001VASF100-092026-09-18
10809160536339HalyardVAHT027-16_0002VAHT027-162026-09-18
10809160536346HalyardVAHT021-14_0002VAHT021-142026-09-18
10809160536353HalyardVAHT024-14_0001VAHT024-142026-09-18
10809160536360HalyardVAHT011-12_0001VAHT011-122026-09-18
10809160536377HalyardVAHT013-17_0001VAHT013-172026-09-18
10809160536384HalyardVAHT017-07_0001VAHT017-072026-09-18
10809160536391HalyardVAHT028-12_0001VAHT028-122026-09-18
10809160536407HalyardVAHT026-21_0001VAHT026-212026-09-18
10809160536414HalyardVAHT019-18_0001VAHT019-182026-09-18
10809160536421HalyardVAHT016-06_0001VAHT016-062026-09-18
10809160536438HalyardVAHT023-13_0001VAHT023-132026-09-18
10809160536445HalyardVAHT006-13_0001VAHT006-132026-09-18
10809160536452HalyardVAHT031-19_0001VAHT031-192026-09-18
10809160536469HalyardVAHT030-18_0001VAHT030-182026-09-18
10809160536476HalyardVAHT032-22_0001VAHT032-222026-09-18
10809160536483HalyardWRNM042-16_0003WRNM042-162026-09-18
10809160536490HalyardEAMC102-10_0016EAMC102-102026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537565HalyardAVID MEDICAL, INC.OES2026-09-19
10809160537763HalyardAVID MEDICAL, INC.OES2026-09-19
10809160537121HalyardAVID MEDICAL, INC.OES2026-09-18
10809160537367HalyardAVID MEDICAL, INC.OES2026-09-18
B098AMS194470Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-18
10198956558687CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-04
10809160532928HalyardAVID MEDICAL, INC.OES2026-09-04
10809160531884HalyardAVID MEDICAL, INC.OES2026-08-27
10809160531891HalyardAVID MEDICAL, INC.OES2026-08-27
10198956557901CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10198956557918CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10198956561762CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10809160531679HalyardAVID MEDICAL, INC.OES2026-08-26
10809160531273HalyardAVID MEDICAL, INC.OES2026-08-21
10809160531280HalyardAVID MEDICAL, INC.OES2026-08-21
10809160531396HalyardAVID MEDICAL, INC.OES2026-08-21
10809160530801HalyardAVID MEDICAL, INC.OES2026-08-19
10198956546301CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-17
10198956554481CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-17
B098AMS188600Aligned Medical SolutionsAligned Medical SolutionsOES2026-08-03
10198956543287CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10198956543614CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10198956544550CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10809160528259HalyardAVID MEDICAL, INC.OES2026-07-31
10198956517776CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956534926CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956535404CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10809160527672HalyardAVID MEDICAL, INC.OES2026-07-21
10198956528062CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-20
10809160527580HalyardAVID MEDICAL, INC.OES2026-07-20