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
10809160532676HalyardMSBS14-05_0006MSBS14-052026-09-04
10809160532683HalyardMSTK53-06_0002MSTK53-062026-09-04
10809160532690HalyardMSCS51-06_0005MSCS51-062026-09-04
10809160532706HalyardSFSBPAR65-02_0003SFSBPAR65-022026-09-04
10809160532713HalyardBPAR65-02_0002BPAR65-022026-09-04
10809160532737HalyardFBCH103-07_0015FBCH103-072026-09-04
10809160532744HalyardMSTK53-07_0001MSTK53-072026-09-04
10809160532768HalyardBKAP27-03_0006BKAP27-032026-09-04
10809160532775HalyardEURO053-02_0003EURO053-022026-09-04
10809160532782HalyardKAFB008-10_0016KAFB008-102026-09-04
10809160532799HalyardWRNM019-16_0003WRNM019-162026-09-04
10809160532805HalyardNAMC436-13_0007NAMC436-132026-09-04
10809160532812HalyardNAMC433-07_0008NAMC433-072026-09-04
10809160532829HalyardWRNM025-12_0005WRNM025-122026-09-04
10809160532836HalyardEAMC1000-05AUX2_0002EAMC1000-05AUX22026-09-04
10809160532843HalyardWRNM007-18_0003WRNM007-182026-09-04
10809160532850HalyardNAMC474-06_0004NAMC474-062026-09-04
10809160532867HalyardBAAK106-15_0002BAAK106-152026-09-04
10809160532874HalyardKAFB009-16_0004KAFB009-162026-09-04
10809160532881HalyardFBCH130-04_0005FBCH130-042026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956522596CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956535589CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956537644CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956552111CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956571679CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956573666CARDINAL HEALTHCardinal Health 200, LLCNWU2026-09-04
10198956530355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548206CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548213CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956548435CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956549258CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956549562CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956550186CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956561168CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956563582CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-26
10198956543973CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956548107CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956556409CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956558830CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-18
10198956542211CARDINAL HEALTHCardinal Health 200, LLCNWU2026-08-17
10198956441842CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956497740CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956501881CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956509511CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956519657CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956537132CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539174CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539891CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956346567CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956373945CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27