FDA.reportPublic FDA data

HALYARD

Primary DI
20885632460309
Brand
HALYARD
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
61344
Device description
HYH No sting skin barrier film 3 ml
Published
2026-02-05
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

Product Codes#

Code, Name table
CodeName
NECBandage, liquid, skin protectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NECBandage, Liquid, Skin ProtectantGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632460309PackageGS14In Commercial Distribution
30885632460306PackageGS125In Commercial Distribution
10885632460302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563246030920885632460309
3088563246030630885632460306
1088563246030210885632460302

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic-polymer liquid barrier dressingA liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05
10885632522659SurgiTrackSM4501306C1C2026-06-05
10885632522543SurgiTrackSM450030A7E12026-06-04
10885632522512SurgiTrackSM45004591012026-06-03
10885632522222SurgiTrackSM45005945A12026-06-01
10885632522109SurgiTrackSM4501306C092026-05-29
10885632522079SurgiTrackSM450045D71A2026-05-28
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16958868743069BiokerzonRoosin Medical Co., Ltd.NEC2026-04-27
08904428721399OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428721405OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745326OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745333OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
10885632460296HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460302HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460319HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460326HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460290HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460313HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460320HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10197344042098MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042111MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
20197344042095MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
30197344042115MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042128MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-23
40197344042129MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-23
10197344042104MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
10197344138906MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
20197344042101MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
20197344138903MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
00500223504328NOVIXSMITH & NEPHEW MEDICAL LIMITEDNEC2026-01-13
00500223504335NOVIXSMITH & NEPHEW MEDICAL LIMITEDNEC2026-01-13
00616784345512Durma+ Unna Boot Bandage with Zinc Oxide and Calamine Dynarex CorporationNEC2025-12-18
00616784345611Durma+ Unna Boot Bandage with Zinc Oxide and Calamine Dynarex CorporationNEC2025-12-18
00616784345413Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
00616784345314Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
00616784345437Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
05000223502706No Sting Skin PrepSMITH & NEPHEW MEDICAL LIMITEDNEC2025-11-26