FDA UDI In Commercial Distribution 🇺🇸 United States

Splash Shield

DI: 00781963451114 · Model: 4511 · BERKLEY MEDICAL RESOURCES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Splash Shield
Primary DI
00781963451114
Version / Model
4511
Company Name
BERKLEY MEDICAL RESOURCES, INC.
Labeler DUNS
077359201
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-05
Public Version
3
Public Version Date
2020-04-06
Public Version Status
Update
Public Device Record Key
315c6101-2b77-45c1-a8b1-5ec49cdda2d5

Device Description

Sold as box of 24

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FXX Mask, Surgical

GMDN Terms

Code Name
11961 Face splash shield, single-use

Identifiers

Type ID
Primary 00781963451114