FDA UDI Not in Commercial Distribution 🇺🇸 United States

JAPANESE, RAPID INFUSER, 100 V, 750 ML/MIN

DI: 20896128002019 · Model: 903-00001-J · BELMONT INSTRUMENT CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
JAPANESE, RAPID INFUSER, 100 V, 750 ML/MIN
Primary DI
20896128002019
Version / Model
903-00001-J
Company Name
BELMONT INSTRUMENT CORPORATION
Labeler DUNS
078330362
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2024-02-19
Public Version Status
Update
Public Device Record Key
8c5ca705-b8f5-4922-b649-12ba9b27892e
Distribution End Date
2023-12-31

Device Description

FLUID WARMER, 100 V SYSTEM BOXED

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LGZ Warmer, Thermal, Infusion Fluid
FRN Pump, Infusion

GMDN Terms

Code Name
17907 Warming/high-flow infusion pump

Identifiers

Type ID
Primary 20896128002019

Premarket Submissions

Submission Number Supplement Number
K032674 000