FDA.reportPublic FDA data

Halyard

Primary DI
30680651488122
Brand
Halyard
Company
Avanos Medical, Inc.
Model
48812
Catalog number
48812
Device description
HYH,PELVI,FLPCH,10
Published
2022-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651488122PackageGS110In Commercial Distribution
10680651488128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065148812230680651488122
1068065148812810680651488128

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
079375431
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651135718Halyard13571PM0062016-08-10
10680651136128Halyard13612PM0022016-08-10
10680651136135Halyard13613PM0032016-08-10
10680651136142Halyard13614PM0042016-08-10
10680651136159Halyard13615PM0052016-08-10
00193494135713ON-Q* Pain Relief System13571PM0062020-05-07
00193494136123ON-Q* Pain Relief System13612PM0022020-05-07
00193494136130ON-Q* Pain Relief System13613PM0032020-05-07
00193494136147ON-Q* Pain Relief System13614PM0042020-05-07
00193494136154ON-Q* Pain Relief System13615PM0052020-05-07
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538999HalyardMEDICAL ACTION INDUSTRIES INC.PUI2026-09-24
10850091824002AeroKEEHealkee Medical USA Inc.PUI2026-09-24
10850091824019AeroKEEHealkee Medical USA Inc.PUI2026-09-24
10197344220083MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-09-18
10197344220090MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-09-18
00197998192814Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998304996Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305016Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305030Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305078Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305092Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305115Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305139Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305153Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312373Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312397Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312434Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312458Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312472Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312496Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329678Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329708Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329739Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329760Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329791Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329821Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329852Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330032Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330124Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330216Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23