FDA UDI In Commercial Distribution 🇺🇸 United States

Hays Innovations

DI: 00869566000240 · Model: H1000S · HAYS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Hays Innovations
Primary DI
00869566000240
Version / Model
H1000S
Catalog Number
H1000S
Company Name
HAYS, INC.
Labeler DUNS
079906040
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-09
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
3054eb6c-6c95-45f6-bfd3-b407fc263ea0

Device Description

Hays Ultrasound kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KKX Drape, Surgical

GMDN Terms

Code Name
45021 Instrument/equipment drape, single-use, sterile

Identifiers

Type ID
Package 00869566000264
Package 00869566000257
Primary 00869566000240