FDA UDI In Commercial Distribution 🇺🇸 United States

SpringBud Fetal Doppler

DI: 06970442090294 · Model: FD-500B · Vcomin Technlogy Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
SpringBud Fetal Doppler
Primary DI
06970442090294
Version / Model
FD-500B
Company Name
Vcomin Technlogy Limited
Labeler DUNS
548312355
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-25
Public Version
2
Public Version Date
2023-08-09
Public Version Status
Update
Public Device Record Key
2fd7f74f-2884-404f-9bb7-d1c317f8ce36

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
No
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KNG Monitor, Ultrasonic, Fetal

GMDN Terms

Code Name
34040 Foetal Doppler system

Identifiers

Type ID
Package 16970442090291
Primary 06970442090294

Premarket Submissions

Submission Number Supplement Number
K182526 000