AccessGUDID - DEVICE: buddy™ Disposable Set (20896128002095)

GUDID

Device Identifier (DI) Information

Brand Name: buddy™ Disposable Set
Version or Model: 905-00010A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 905-00010A
Company Name: BELMONT INSTRUMENT CORPORATION

Primary DI Number: 20896128002095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078330362 *Terms of Use

Device Description: 6 X Box 24=144

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":	Yes
For Single-Use:	Yes
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?
47618	Conduction blood/fluid warmer set	A collection of devices used in conjunction with a conduction blood/fluid warmer to heat banked blood, blood products, and intravenous (IV) fluids to a temperature appropriate for infusion into a patient. It consists of a pouch(es) or a flexible cassette through which blood/fluid flows from the infusion bag to the patient while being heated in-line by the warmer; clamps and a bubble trap may be included. The set is typically used in the operating room (OR) or in accident and emergency (A&E) situations when rapid infusion of several units of blood/fluid is necessary. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSB	Warmer, Blood, Non-Electromagnetic Radiation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 7c7201d0-8eb0-4723-938f-75f999efb14a
Public Version Date: April 23, 2024
Public Version Number: 1
DI Record Publish Date: April 15, 2024