FDA.reportPublic FDA data

Halyard

Primary DI
20680651718253
Brand
Halyard
Company
O&M HALYARD, INC.
Model
71825
Catalog number
71825
Device description
Standard Telemetry Unit Pouch
Published
2020-11-16
Public version status
Update
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
DSWBAG, POLYMERIC MESH, PACEMAKER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSWBag, Polymeric Mesh, PacemakerCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651718250PackageGS14In Commercial Distribution
20680651718253PrimaryGS10
90680651718252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065171825030680651718250
2068065171825320680651718253
9068065171825290680651718252

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, belt or strap intended to pass through the personal device’s slots, or clothing. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
081057389
Device count
15
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20680651509646Halyard50964509642026-05-14
20680651509653Halyard50965509652026-05-14
20680651509660Halyard50966509662026-05-14
20680651509677Halyard50967509672026-05-14
20680651509684Halyard50968509682026-05-14
20680651484219Halyard48421484212022-05-06
20680651484226Halyard48422484222022-05-06
10680651385250Halyard38525385252023-07-31
20680651372219Halyard37221372212020-11-16
20680651372509Halyard37250372502020-11-16
20680651718000Halyard71800718002020-08-31
20680651719007Halyard71900719002020-11-16
30680651494390Halyard49439494392025-03-26
30680651494406Halyard49440494402025-03-26
30680651494413Halyard49441494412025-03-26
30680651494420Halyard49442494422025-03-26
30680651494437Halyard49443494432025-03-26
20680651395072Halyard39507395072020-09-15
20680651395089Halyard39508395082020-09-15
20680651506010Halyard50601506012020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20326053123522Regard™Resource Optimization & Innovation, L.L.C.DSW2026-03-11
20326053123539Regard™Resource Optimization & Innovation, L.L.C.DSW2026-03-11
00326053123528Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.DSW2026-03-11
00326053123535Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.DSW2026-03-11
20680651719007HalyardO&M HALYARD, INC.DSW2020-11-16
30680651718250HalyardO&M HALYARD, INC.DSW2020-11-16
30680651719004HalyardO&M HALYARD, INC.DSW2020-11-16
20680651718000HalyardO&M HALYARD, INC.DSW2020-08-31
30680651718007HalyardO&M HALYARD, INC.DSW2020-08-31
00801741040955Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
00801741040962Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
00801741040979Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
10801741040952Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
10801741040969Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25
10801741040976Bard® Parsonnet Pulse Generator PouchesBard Peripheral Vascular, Inc.DSW2015-09-25