FDA UDI In Commercial Distribution 🇺🇸 United States

DK50 DS

DI: 08586014625047 · Model: BAS NOZ 115V 60Hz 3bar NO MEK · EKOM spol. s r.o.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
DK50 DS
Primary DI
08586014625047
Version / Model
BAS NOZ 115V 60Hz 3bar NO MEK
Company Name
EKOM spol. s r.o.
Labeler DUNS
360551766
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-14
Public Version
1
Public Version Date
2023-06-22
Public Version Status
New
Public Device Record Key
87fbb601-aca6-485e-9ab1-10d9198ee24a

Device Characteristics

Single Use
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BTI Compressor, Air, Portable

GMDN Terms

Code Name
31253 Medical device air compressor

Identifiers

Type ID
Primary 08586014625047

Premarket Submissions

Submission Number Supplement Number
K091871 000