FDA.report

GI SOURCE

Primary DI
00840216119345
Brand
GI SOURCE
Company
Asp Global, LLC
Model
2812
Device description
2812 YW TUBULAR SPONGE DRY, 1/EA,100/CS
Published
2022-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications

CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216119345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216119345008402161193458402161193450840216119345

GMDN Terms

TermDefinition
Medical device cleaning sponge/setA hand-held manual device in the form of a soft or abrasive sponge/pad, sometimes with non-medicated substances (e.g., enzymes, surfactant) and potentially other related items (e.g., receptacle), intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080361159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00724995233327DuoswiftUS EndoscopyMNL2026-03-12
00817169024989Pristine by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMNL2026-03-05
10850075039002Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039033Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039057Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039071Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039095Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039118Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039125Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039156Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039194Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10850075039217Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10860002853106Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
00860002853192Venturi MicroDryerGI SCIENTIFIC LLCMNL2026-02-10
10860007020909Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
10860007020947Venturi CleanGI SCIENTIFIC LLCMNL2026-02-10
20860007020968Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
00860007020971Venturi DryGI SCIENTIFIC LLCMNL2026-02-10
10850075039149Venturi DryGI SCIENTIFIC LLCMNL2026-02-09
00190776415686MillenniumAvalign Technologies, Inc.MNL2026-02-04
00198506087370ELMED INCORPORATEDELMED INCORPORATEDMNL2026-01-07
G4533352003290PEAK MEDICALPeak Medical Distribution Inc.MNL2026-01-05
G4533353003310PEAK MEDICALPeak Medical Distribution Inc.MNL2026-01-05
00850067560227LaproClearSurgical Principals, IncMNL2025-12-11
00816185001165AquaBrush SystemTorvan Medical IncMNL2025-12-08
16936603228934Single Use Angulation Knob ExtenderYangzhou Fartley Medical Instrument Technology Co., LtdMNL2025-12-03
16936603231736Single-Use ErgoGrip Knob ExtenderYangzhou Fartley Medical Instrument Technology Co., LtdMNL2025-12-03
00198506018268ELMED INCORPORATEDELMED INCORPORATEDMNL2025-09-05
00198506084775ELMED INCORPORATEDELMED INCORPORATEDMNL2025-08-26
00198506084782ELMED INCORPORATEDELMED INCORPORATEDMNL2025-08-26