FDA.reportPublic FDA data

SOMAVAC Belt Extender

Primary DI
10850004219062
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
OTC
false
Sterile
false
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 patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag) 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, strap, belt, or clothing. This is a single-use device.

Sterilization Methods#

Method table
Method

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10850004219079SOMAVAC Drain Connector - Dual Input10061100612020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420060206036haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206043haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206050haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206067haakaaTHINK GREEN LIMITEDGCY2026-09-20
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
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
04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
00848530106973Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106980Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106997Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107000Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107017Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530106966Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-14
00848530107185Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-08-12
00848530106164Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530106171Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530106188Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-07-02
00848530095222Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106201Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106218Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106225Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106232Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106256Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106263Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106270Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530104467Suction KitSunset Healthcare Solutions, Inc.GCY2025-04-14