FDA.reportPublic FDA data

SOMAVAC Waste Collection Unit

Primary DI
00850004219041
Brand
SOMAVAC Waste Collection Unit
Company
Somavac Medical Solutions, Inc.
Model
20021
Catalog number
20021
Device description
Disposable waste collection unit for SOMAVAC Sustained Vacuum System with 100cc total capacity.
Published
2019-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10850004219048PackageGS15In Commercial Distribution
10850004219086PackageGS120In Commercial Distribution
00850004219041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000421904810850004219048
1085000421908610850004219086
00850004219041008500042190418500042190410850004219041

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080446796
Device count
1
Lot or batch
true
Manufacturing 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
00850004219027SOMAVAC 100 Sustained Vacuum System10011100112019-08-30
00850004219034SOMAVAC Drain Connector20031200312019-12-24
00850004219058SOMAVAC Belt20041200412019-11-08
10850004219079SOMAVAC Drain Connector - Dual Input10061100612020-12-18
10850004219062SOMAVAC Belt Extender20051200512019-11-08

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Primary DI, Brand, Company table
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04710969717920Uresil Evolution Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLECanadian Hospital Specialties LimitedGCY2026-08-18
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