FDA.reportPublic FDA data

SOMAVAC Drain Connector - Dual Input

Primary DI
10850004219079
Brand
SOMAVAC Drain Connector - Dual Input
Company
SOMAVAC MEDICAL SOLUTIONS, INC.
Model
10061
Catalog number
10061
Device description
Somavac Drain Connector with two inputs and a single output.
Published
2020-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
10850004219079PackageGS11In Commercial Distribution
00850004219072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000421907910850004219079
00850004219072008500042190728500042190720850004219072

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain connection tubing setA device collection which includes flexible, noninvasive, single-lumen tubing with connectors at each end intended to provide a connection between a surgical drainage catheter(s) and a closed-wound drainage suction pump; it also includes a one-way valve and/or filter. 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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
080446796
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
00850004219027SOMAVAC 100 Sustained Vacuum System10011100112019-08-30
00850004219034SOMAVAC Drain Connector20031200312019-12-24
00850004219041SOMAVAC Waste Collection Unit20021200212019-08-23
00850004219058SOMAVAC Belt20041200412019-11-08
10850004219062SOMAVAC Belt Extender20051200512019-11-08

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Primary DI, Brand, Company table
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