AccessGUDID - DEVICE: Rapid Infuser RI-2, 120V, 750 ml/min (10896128002760)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid Infuser RI-2, 120V, 750 ml/min
Version or Model: 903-00039
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BELMONT INSTRUMENT CORPORATION

Primary DI Number: 10896128002760
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078330362 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17907	Warming/high-flow infusion pump	A mains electricity (AC-powered) device designed to warm and rapidly infuse blood and other solutions (e.g., crystalloid and colloid) into a patient during high-blood-loss surgical procedures; it is also used for burn and trauma cases. Maximum flow rates may exceed 1 L/min.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242735	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 79f1eb3e-c4b1-46fe-a2ca-2147875df290
Public Version Date: January 08, 2025
Public Version Number: 5
DI Record Publish Date: September 23, 2016