FDA.reportPublic FDA data

Halyard

Primary DI
20680651299653
Brand
Halyard
Company
O&M HALYARD, INC.
Model
29965
Catalog number
29965
Device description
HALYARD* I.V. Support, Neonatal
Published
2020-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILHSPLINT, HAND, AND COMPONENTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651299650PackageGS13In Commercial Distribution
20680651299653PrimaryGS10
90680651299652Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065129965030680651299650
2068065129965320680651299653
9068065129965290680651299652

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, single-useA device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., to maintain the patency of an intravenous (IV) needle or an intravascular catheter]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and may be attached or fixed (e.g., onto a side rail). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
081057389
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651487616PUREZERO* MARIN* XTRA*48761487612022-06-06
20680651487623PUREZERO* MARIN* XTRA*48762487622022-06-06
20680651487630PUREZERO* MARIN* XTRA*48763487632022-06-06
20680651487647PUREZERO* MARIN* XTRA*48764487642022-06-06
20680651487654PUREZERO* MARIN* XTRA*48765487652022-06-06
20680651487661PUREZERO* MARIN*48766487662022-06-06
20680651487678PUREZERO* MARIN*48767487672022-06-06
20680651487685PUREZERO* MARIN*48768487682022-06-06
20680651487692PUREZERO* MARIN*48769487692022-06-06
20680651487708PUREZERO* MARIN*48770487702022-06-06
20680651497639Halyard49763ARMOR242026-07-16
20680651497646Halyard49764ARMOR362026-07-16
20680651497653Halyard49765ARMOR402026-07-16
20680651497660Halyard49766ARMOR452026-07-16
20680651497677Halyard49767ARMOR482026-07-16
20680651497684Halyard49768ARMOR542026-07-16
30680651496936Halyard49693496932025-05-17
30680651496943Halyard49694496942025-05-17
30680651496950Halyard49695496952025-05-17
30680651496967Halyard49696496962025-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226443006ViveVIVE HEALTH LLCILH2026-10-20
00194346210794EquateWAL-MART STORES, INC.ILH2026-10-14
00810226442870ViveVIVE HEALTH LLCILH2026-10-12
00810226442887ViveVIVE HEALTH LLCILH2026-10-12
00810226442894ViveVIVE HEALTH LLCILH2026-10-12
00810226442900ViveVIVE HEALTH LLCILH2026-10-12
00810179882365CopperFitIdeavillage Products CorpILH2026-10-01
00810179882372CopperFitIdeavillage Products CorpILH2026-10-01
00810179882662CopperFitIdeavillage Products CorpILH2026-10-01
00810179882679CopperFitIdeavillage Products CorpILH2026-10-01
50609576700274Puritan®Puritan Medical ProductsILH2026-07-27
06974546525140TealmedNingbo Tealmed Emergency Products Co., Ltd.ILH2026-06-25
00810226440036ViveVIVE HEALTH LLCILH2026-06-03
00810226440043ViveVIVE HEALTH LLCILH2026-06-03
00057475274139BIOS LivingThermor LtdILH2023-09-18
00057475274313BIOS LivingThermor LtdILH2023-09-18
00057475210175BIOS LivingThermor LtdILH2023-09-15
00057475210182BIOS LivingThermor LtdILH2023-09-15
10680651299854HalyardO&M HALYARD, INC.ILH2023-07-31
20680651299004HalyardO&M HALYARD, INC.ILH2023-06-07
B7685810200Buxton BioMedicalBUXTON BIOMEDICAL, INC.ILH2023-05-26
00057475210441BIOS LivingThermor LtdILH2023-03-31
00057475210472BIOS LivingThermor LtdILH2023-03-31
00609271100053DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100152DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100251DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100350DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271100459DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101050DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08
00609271101159DARCO® Bungee wrist braceDARCO INTERNATIONAL, INC.ILH2023-02-08