FDA.reportPublic FDA data

SOMAVAC 100 Sustained Vacuum System

Primary DI
00850004219027
Brand
SOMAVAC 100 Sustained Vacuum System
Company
Somavac Medical Solutions, Inc.
Model
10011
Catalog number
10011
Device description
Portable, battery powered vacuum source with waste containers and accessories.
Published
2019-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180606000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180606000SOMAVAC DeviceSomavac Medical Solutions, Inc.2018-05-31BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004219027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004219027008500042190278500042190270850004219027

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainage suction pumpA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080446796
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004219065SOMAVAC Belt Extender20051200512019-11-08
00850004219072SOMAVAC Drain Connector - Dual Input10061100612020-12-18
00850004219096SOMAVAC Drain Connector - Dual Output10081100812020-12-18
00850004219010SOMAVAC 100 Vacuum Source20011200112019-08-30
00850004219034SOMAVAC Drain Connector20031200312019-12-24
00850004219041SOMAVAC Waste Collection Unit20021200212019-08-23
00850004219058SOMAVAC Belt20041200412019-11-08
10850004219079SOMAVAC Drain Connector - Dual Input10061100612020-12-18
10850004219062SOMAVAC Belt Extender20051200512019-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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