AccessGUDID - DEVICE: SOMAVAC 100 Vacuum Source (00850004219010)

GUDID

Device Identifier (DI) Information

Brand Name: SOMAVAC 100 Vacuum Source
Version or Model: 20011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20011
Company Name: SOMAVAC MEDICAL SOLUTIONS, INC.

Primary DI Number: 00850004219010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080446796 *Terms of Use

Device Description: Portable battery powered vacuum source at 100mmHg

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":	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?
64400	Closed-wound drainage suction pump	A patient-worn, noninvasive, electrically-powered device intended to generate negative pressure for the continuous aspiration of surgical and/or bodily fluids from a closed-wound, via an in situ drain/catheter (not included), typically following a surgical procedure. It may include noninvasive accessories (e.g., collection bag), however it does not include invasive devices. It may be used in the home and in clinical settings. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered
BTA	Pump, Portable, Aspiration (Manual Or Powered)

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: 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: 746c08bf-c8cc-4a6f-a976-27e464a17a45
Public Version Date: March 24, 2021
Public Version Number: 2
DI Record Publish Date: August 30, 2019