AccessGUDID - DEVICE: Swabbable Valve Transfer Set (00616258024554)

GUDID

Device Identifier (DI) Information

Brand Name: Swabbable Valve Transfer Set
Version or Model: SVTS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SVTS
Company Name: Bayer Medical Care Inc.

Primary DI Number: 00616258024554
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 049673973 *Terms of Use

Device Description: ASSY,TBG,SWAB VALV,TNSFR SET,MC,CORE (87622584)

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
FPK	Tubing, Fluid Delivery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031808	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
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d8c0ee8-2361-4e82-bf4e-29c48ca3b5d2
Public Version Date: May 14, 2024
Public Version Number: 1
DI Record Publish Date: May 06, 2024