FDA UDI In Commercial Distribution 🇺🇸 United States

Hummi Micro-Draw

DI: 10817522013305 · Model: ABG-HM-1 · KENTEC MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Hummi Micro-Draw
Primary DI
10817522013305
Version / Model
ABG-HM-1
Catalog Number
ABG-HM-1
Company Name
KENTEC MEDICAL, INC.
Labeler DUNS
066175613
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-03
Public Version
1
Public Version Date
2021-06-11
Public Version Status
New
Public Device Record Key
e31b36f9-47c6-444c-9921-fdf021867e2e

Device Description

hummi micro draw

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
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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KST System, Blood Collection, Vacuum-Assisted, Manual

GMDN Terms

Code Name
31336 Arterial blood sampling kit

Identifiers

Type ID
Package 20817522013302
Primary 10817522013305

Customer Contacts

Phone
949-863-0810