FDA UDI In Commercial Distribution 🇺🇸 United States

Halyard

DI: 30680651763823 · Model: 76382 · O&M HALYARD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
14

Basic Information

Brand Name
Halyard
Primary DI
30680651763823
Version / Model
76382
Catalog Number
76382
Company Name
O&M HALYARD, INC.
Labeler DUNS
081057389
Distribution Status
In Commercial Distribution
Device Count in Pkg
14
Record Status
Published
Publish Date
2019-10-07
Public Version
3
Public Version Date
2021-11-01
Public Version Status
Update
Public Device Record Key
73409dab-9f46-42c8-96aa-a17d449c5531

Device Description

Pediatric Femoral Angiography Drape 76 in. x 122 in./193 cm x 310 cm

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
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KKX Drape, surgical

GMDN Terms

Code Name
47782 Patient surgical drape, single-use, non-sterile

Identifiers

Type ID
Primary 30680651763823
Unit of Use 90680651763825

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K842115 000