FDA.reportPublic FDA data

Halyard

Primary DI
30680651771538
Brand
Halyard
Company
O&M HALYARD, INC.
Model
77153
Catalog number
77153
Device description
SMS Isolation Gown with Knitted Cuff, Yellow, Universal Size
Published
2020-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEANon-surgical isolation gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20680651771531PrimaryGS10
30680651771538PrimaryGS10
90680651771530Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2068065177153120680651771531
3068065177153830680651771538
9068065177153090680651771530

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
081057389
Device count
10
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30680651501272Halyard50127NS50127NS2026-06-08
30680651501289Halyard50128NS50128NS2026-06-08
30680651501296Halyard50129NS50129NS2026-06-08
30680651501302Halyard50130NS50130NS2026-06-08
10680651497571Halyard49757497572026-06-06
10680651497588Halyard49758497582026-06-06
10680651497595Halyard49759497592026-06-06
20680651500674Halyard50067500672026-06-04
20680651500681Halyard50068500682026-06-04
20680651500698Halyard50069500692026-06-04
20680651500704Halyard50070500702026-06-04
20680651500711Halyard50071500712026-06-04
20680651502388Halyard50238502382026-06-04
20680651502395Halyard50239502392026-06-04
20680651502401Halyard50240502402026-06-04
20680651502418Halyard50241502412026-06-04
20680651502425Halyard50242502422026-06-04
30680651424465Halyard42446NS42446NS2026-06-02
20680651509646Halyard50964509642026-05-14
20680651509653Halyard50965509652026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
00842942017506PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
00842942017513PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
00842942015700PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942015717PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017261PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017278PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942007934PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942008047PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009570PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009587PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014406PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014420PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015298PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015427PRIMEDpriMED Medical Products IncOEA2025-07-15
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCOEA2025-03-22
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106743256CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-20
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
10193489099560MEDLINEMEDLINE INDUSTRIES, INC.OEA2024-07-04
10197106675250CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-27
10197106665183CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-25