FDA.reportPublic FDA data

HALYARD

Primary DI
10809160528358
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
PVHM229-02
Catalog number
PVHM229-02
Published
2026-08-01
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10809160528358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916052835810809160528358

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopy preparation kitA collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

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
10809160540862HalyardHOHD26-01_0006HOHD26-012026-10-20
10809160540886HalyardFBCH113-03_0007FBCH113-032026-10-20
10809160540893HalyardNAFB055-10_0004NAFB055-102026-10-20
10809160540909HalyardNAFB024-12_0006NAFB024-122026-10-20
10809160540916HalyardNAFB057-06_0004NAFB057-062026-10-20
10809160540923HalyardNAFB082-06_0003NAFB082-062026-10-20
10809160540930HalyardNAFB066-11_0003NAFB066-112026-10-20
10809160540947HalyardMSBS14-06MSBS14-062026-10-20
10809160540954HalyardSAMM022-22_0003SAMM022-222026-10-20
10809160540961HalyardVALV224-05_0014VALV224-052026-10-20
10809160540978HalyardVALV223-06_0008VALV223-062026-10-20
10809160540985HalyardSTVA013-06_0009STVA013-062026-10-20
10809160540787HalyardBPVP85-01_0002BPVP85-012026-10-19
10809160540794HalyardTNCA09_0007TNCA092026-10-19
10809160540800HalyardJCLC12F_0009JCLC12F2026-10-19
10809160540817HalyardMWOS97-02MWOS97-022026-10-19
10809160540824HalyardUSAR034-20_0013USAR034-202026-10-19
10809160540831HalyardEURO055-01_0007EURO055-012026-10-19
10809160540664HalyardDUDV85-02_0001DUDV85-022026-10-16
10809160540671HalyardDAGV13-03_0001DAGV13-032026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956553903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956569331CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956595965CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956598355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956602236CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605442CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605497CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605640CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956607743CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609723CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609976CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956612648CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10809160540756HALYARDAVID MEDICAL, INC.NWU2026-10-16
10198956565388CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956596054CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956602274CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956589810CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-13
10198956598775CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-13
10198956391239CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956553408CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956556522CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956564701CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956574595CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956577077CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956584150CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956590793CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956590809CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956592742CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956598324CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956601826CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12