AccessGUDID - DEVICE: MEDRAD Imaging Bulk Package Transfer Spike (00616258022369)

GUDID

Device Identifier (DI) Information

Brand Name: MEDRAD Imaging Bulk Package Transfer Spike
Version or Model: GBP TS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GBP TS
Company Name: Bayer Medical Care Inc.

Primary DI Number: 00616258022369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049673973 *Terms of Use

Device Description: ASSY,IBP TRANSFER SPIKE,FINAL (86613735)

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":	Yes
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?
43324	Fluid transfer set, general-purpose	A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQH	Iodinated Contrast Media Transfer Tubing Set

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200280	000

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: 6bcba898-903d-4353-96e3-2922c8eea0e8
Public Version Date: April 23, 2024
Public Version Number: 1
DI Record Publish Date: April 15, 2024