FDA.reportPublic FDA data

Halyard

Primary DI
20809160373238
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
NAFB049-05_0004
Catalog number
NAFB049-05
Published
2022-06-14
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160373238PackageGS16In Commercial Distribution
10809160373231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916037323820809160373238
1080916037323110809160373231

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26
10809160521847HalyardARMC007-02_0007ARMC007-022026-05-26
10809160521731HalyardWINN122-09_0004WINN122-092026-05-22
10809160521762HalyardUSAR061-08_0004USAR061-082026-05-22
10809160521779HalyardWINN112-06_0014WINN112-062026-05-22
10809160521786HalyardUIPP85-02UIPP85-022026-05-22
10809160521793HalyardWINN112-06_0002WINN112-062026-05-22
10809160521809HalyardESFS76-01_0007ESFS76-012026-05-22
10809160521700HalyardDULP98-02_0001DULP98-022026-05-21
10809160521717HalyardLHMB9513-01_0004LHMB9513-012026-05-21
10809160521724HalyardNIHB0021-13_0003NIHB0021-132026-05-21
10809160521649HalyardNIHB0009-11_0007NIHB0009-112026-05-20
10809160521656HalyardNIHB0021-13_0011NIHB0021-132026-05-20
10809160521663HalyardNIHB0026-10_0003NIHB0026-102026-05-20
10809160521670HalyardNIHB0036-08_0006NIHB0036-082026-05-20
10809160521687HalyardNIHB0024-08_0006NIHB0024-082026-05-20
10809160521694HalyardWINN121-11_0002WINN121-112026-05-20
10809160521618HalyardSLCL55-02_0002SLCL55-022026-05-19

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Primary DI, Brand, Company table
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