FDA UDI In Commercial Distribution 🇺🇸 United States

Halyard

DI: 10885632431159 · Model: 55619 · O&M HALYARD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Halyard
Primary DI
10885632431159
Version / Model
55619
Catalog Number
55619
Company Name
O&M HALYARD, INC.
Labeler DUNS
081057389
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-11-12
Public Version
1
Public Version Date
2024-11-20
Public Version Status
New
Public Device Record Key
65fd54ac-39a0-46f4-a823-9a9456e2c1f0

Device Description

HALYARD* Conforming Skin Barrier Ring 4 in OD

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EZS Appliance, colostomy, disposable

GMDN Terms

Code Name
46207 Peristomal/periwound dressing

Identifiers

Type ID
Package 30885632431153
Primary 10885632431159

Customer Contacts