FDA.report

ASP MEDICAL

Primary DI
00840216108271
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
PPA030
Device description
PAD, ALCOHOL PREP, STERILE, LARGE
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LKBPad, Alcohol, Device Disinfectant

Product Code Classifications

CodeDeviceSpecialtyClass
LKBPad, Alcohol, Device DisinfectantUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216108271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216108271008402161082718402161082710840216108271

GMDN Terms

TermDefinition
Skin-cleaning wipe, sterileA sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods

Method
Radiation Sterilization

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
true
No natural rubber latex
false
Sterilization required before use
true

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

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10192253045727WebcolCardinal Health 200, LLCLKB2025-06-12
20192253047063WebcolCardinal Health 200, LLCLKB2025-06-10
10860000526514True Comfort Alcohol PadsHOME AIDE DIAGNOSTICS, INC.LKB2024-10-08
00653160373851MEDLINEMEDLINE INDUSTRIES, INC.LKB2024-04-25
00310819000031Prevantics® Device Large Swab PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.LKB2024-02-15
20850049784539SURGYCOSurgyco LLCLKB2023-12-15
20850049784553SURGYCOSurgyco LLCLKB2023-12-15
00801741086939SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
00801741086946SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
10192253047097WebcolCardinal Health 200, LLCLKB2023-10-09
06972403307564ZDXuchang Zhende Surgical Dressing Co., Ltd.LKB2023-06-28
10810132040785HCSConcordance Healthcare Solutions LLCLKB2023-05-01
10810132040792HCSConcordance Healthcare Solutions LLCLKB2023-05-01
10891153001184TempoHemasource, Inc.LKB2022-12-08
10891153001733TempoHemasource, Inc.LKB2022-12-08
20618407611053APLICAREMEDLINE INDUSTRIES, INC.LKB2022-12-06
20618407631051APLICAREMEDLINE INDUSTRIES, INC.LKB2022-12-06
00665973025070DukalDukal LLCLKB2022-12-06
04711908601737CSDCHINA SURGICAL DRESSINGS CENTER CO., LTD.LKB2022-11-10
00840216108639ASP MEDICALAsp Global, LLCLKB2022-08-31
10850632007758ZevRx Alcohol Pads 100cntHOME AIDE DIAGNOSTICS, INC.LKB2022-08-16
50749756371280DeRoyalDEROYAL INDUSTRIES, INC.LKB2021-08-23
10850027494125True Comfort Pro Alcohol PadsHOME AIDE DIAGNOSTICS, INC.LKB2021-03-29
10850632007154SAPS Health alcohol padsHOME AIDE DIAGNOSTICS, INC.LKB2021-03-29
10860006377806SAPS Health Plus Alcohol PadsHOME AIDE DIAGNOSTICS, INC.LKB2021-03-29
00891237001959BaaySCI Alcohol Disinfecting Prep PadsHOME AIDE DIAGNOSTICS, INC.LKB2021-03-29
20862850000319Pharmacist ChoiceSIMPLE DIAGNOSTICS INCLKB2020-09-01
10894046001384Advocate Prep PadsDIABETIC SUPPLY OF SUNCOAST, INC.LKB2020-09-01