FDA.reportPublic FDA data

SOMAVAC Belt Extender

Primary DI
00850004219065
Brand
SOMAVAC Belt Extender
Company
Somavac Medical Solutions, Inc.
Model
20051
Catalog number
20051
Device description
Extender for SOMAVAC Belt, 80 in.
Published
2019-11-08
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
10850004219062PackageGS12In Commercial Distribution
00850004219065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000421906210850004219062
00850004219065008500042190658500042190650850004219065

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA portable, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, belt or strap intended to pass through the personal device’s slots, or clothing. This is a single-use device.

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
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
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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04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
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04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
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