FDA.reportPublic FDA data

SOMAVAC Drain Connector

Primary DI
00850004219034
Brand
SOMAVAC Drain Connector
Company
Somavac Medical Solutions, Inc.
Model
20031
Catalog number
20031
Device description
Filter and check valve; one end barb, one end Luer.
Published
2019-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10850004219031PackageGS15In Commercial Distribution
00850004219034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000421903110850004219031
00850004219034008500042190348500042190340850004219034

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
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
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
Primary DIBrandCompanyProduct codePublished
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10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
10197106600788CARDINAL HEALTHCardinal Health 200, LLCGCY2024-03-25
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10197106520932CARDINAL HEALTHCardinal Health 200, LLCGCY2024-01-24
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