AccessGUDID - DEVICE: SOMAVAC Drain Connector - Dual Output (00850004219096)

GUDID

Device Identifier (DI) Information

Brand Name: SOMAVAC Drain Connector - Dual Output
Version or Model: 10081
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10081
Company Name: SOMAVAC MEDICAL SOLUTIONS, INC.

Primary DI Number: 00850004219096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080446796 *Terms of Use

Device Description: Sterile Drain Connector with a single input and two outputs.

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:	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?
64512	Closed-wound drain connection tubing set	A device collection which includes flexible, noninvasive tubing (typically single or Y-shaped) and associated items (typically connectors, clamps, one-way valve and/or filter) intended to provide a connection between a surgical drain(s)/catheter(s) and a wound drainage container and/or suction source (the catheter, container and suction source are not included) to drain a closed wound. It is not intended to connect components of a surgical suction system (i.e., not used during general surgery). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180606	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: 28f6a8a6-c3d8-436f-8b85-a80d7b8248e5
Public Version Date: January 20, 2023
Public Version Number: 2
DI Record Publish Date: December 18, 2020