AccessGUDID - DEVICE: Swedish, Rapid Infuser, 230 V, 750ml/min (00896128002350)

GUDID

Device Identifier (DI) Information

Brand Name: Swedish, Rapid Infuser, 230 V, 750ml/min
Version or Model: 903-00001A-SW
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BELMONT INSTRUMENT CORPORATION

Primary DI Number: 00896128002350
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 078330362 *Terms of Use

Device Description: Fluid Warmer, 230V UNIT, 750ml/min

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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
FRN	Pump, Infusion
LGZ	Warmer, Thermal, Infusion Fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091855	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: c0cd62f8-0827-4704-b854-04107475fda9
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016