FDA.reportPublic FDA data

Foam Swab 20 Pack

Primary DI
10857808005228
Brand
Foam Swab 20 Pack
Company
ASPIRE BARIATRICS, INC.
Model
100-0019
Catalog number
100-0019
Device description
Foam Swab 20 Pack
Published
2016-07-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OYFAspiration Therapy System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYFAspiration Therapy SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150024000AspireAssistAspire Bariatrics, Inc.2016-06-14OYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857808005228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085780800522810857808005228

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy aspiration system gravity setA collection of non-sterile devices designed as the external portion of a gastrostomy aspiration system intended to be used post-surgery by the patient after implantation of the stomach tube for the removal of a portion of stomach contents after meals, by aspiration, to achieve portion control and subsequently weight loss in a morbidly obese (bariatric) patient (= 18 years). It typically consists of a connector (connects to the stomal skin port), water reservoir, drain tube, and control valves to facilitate alternating water infusion and aspiration by gravity. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
877-312-0007quality@aspirebariatrics.com

Regulatory Flags#

DUNS number
026281163
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10857808005419Aspire Introducer Needle100-0035100-00352018-08-13
10857808005891Aspire Venting Tube Kit100-0047100-00472019-01-25
10857808005013AspireAssist A-Tube Pack200-0044200-00442016-07-25
10857808005020AspireAssist A-Tube Kit100-0011-LANG A100-0011-LANG A2016-07-25
10857808005037AspireAssist A-Tube Kit100-0011-LANG B100-0011-LANG B2016-07-25
10857808005044AspireAssist A-Tube Kit100-0011-LANG C100-0011-LANG C2016-07-25
10857808005471AspireAssist A-Tube Kit100-0011-US100-0011-US2016-07-25
10857808005051AspireAssist Connector-LANG A200-0019-LANG A200-0019-LANG A2016-07-25
10857808005068AspireAssist Connector-LANG B200-0019-LANG B200-0019-LANG B2016-07-25
10857808005075AspireAssist Connector-LANG C200-0019-LANG C200-0019-LANG C 2016-07-25
10857808005082AspireAssist Reservoir 100-0012100-00122016-07-25
10857808005099AspireAssist Companion, Blue-LANG A100-0013-LANG A100-0013-LANG A2016-07-25
10857808005105AspireAssist Companion, Blue-LANG B100-0013-LANG B100-0013-LANG B 2016-07-25
10857808005112AspireAssist Companion, Blue-LANG C100-0013-LANG C100-0013-LANG C2016-07-25
10857808005129AspireAssist Companion, Magenta-LANG A100-0014-LANG A100-0014-LANG A2016-07-25
10857808005136AspireAssist Companion, Magenta-LANG B100-0014-LANG B100-0014-LANG B2016-07-25
10857808005143AspireAssist Companion, Magenta-LANG C100-0014-LANG C100-0014-LANG C2016-07-25
10857808005150AspireAssist Tubing Set100-0016100-00162016-07-25
10857808005167AspireAssist Starter Kit, Blue-LANG A100-0017-LANG A100-0017-LANG A2016-07-25
10857808005174AspireAssist Starter Kit, Blue-LANG B100-0017-LANG B100-0017-LANG B2016-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10857808005266AspireAssist Skin-Port-LANG AASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005273AspireAssist Skin-Port-LANG BASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005280AspireAssist Skin-Port-LANG CASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005297AspireAssist Skin-Port Sleeve, Multipack (5x)-LANG AASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005303AspireAssist Skin-Port Sleeve, Multipack (5x)-LANG BASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005310AspireAssist Skin-Port Sleeve, Multipack (5x)-LANG CASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005327AspireAssist Skin-Port Installation Tool Kit-LANG AASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005334AspireAssist Skin-Port Installation Tool Kit-LANG BASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005341AspireAssist Skin-Port Installation Tool Kit-LANG CASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005358AspireAssist First Year Kit, Blue-LANG A ASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005365AspireAssist First Year Kit, Blue-LANG B ASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005372AspireAssist First Year Kit, Blue-LANG C ASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005389AspireAssist First Year Kit, Magenta-LANG AASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005396AspireAssist First Year Kit, Magenta-LANG BASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005402AspireAssist First Year Kit, Magenta-LANG CASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005501AspireAssist Companion, Blue-USASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005518AspireAssist Companion, Magenta-USASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005525AspireAssist Starter Kit, Blue-USASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005532AspireAssist Starter Kit, Magenta-USASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005549AspireAssist Skin-Port-USASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005556AspireAssist Skin-Port Sleeve, Multipack (5x)-USASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005563AspireAssist Skin-Port Installation Tool Kit-USASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005570AspireAssist First Year Kit, Blue-USASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005587AspireAssist First Year Kit, Magenta-USASPIRE BARIATRICS, INC.OYF2016-07-26
10857808005051AspireAssist Connector-LANG AASPIRE BARIATRICS, INC.OYF2016-07-25
10857808005068AspireAssist Connector-LANG BASPIRE BARIATRICS, INC.OYF2016-07-25
10857808005075AspireAssist Connector-LANG CASPIRE BARIATRICS, INC.OYF2016-07-25
10857808005082AspireAssist Reservoir ASPIRE BARIATRICS, INC.OYF2016-07-25
10857808005099AspireAssist Companion, Blue-LANG AASPIRE BARIATRICS, INC.OYF2016-07-25
10857808005105AspireAssist Companion, Blue-LANG BASPIRE BARIATRICS, INC.OYF2016-07-25