FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216105027
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
UNT101
Device description
UNDERPAD, 17" X 24"
Published
2022-08-15
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

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216105027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216105027008402161050278402161050270840216105027

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, non-antimicrobial, single-useA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Sterilization Methods#

Method table
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859149975678DRY PADPHU BAO GROUP COMPANY LIMITEDKME2026-03-17
00885914997581DRY PADPHU BAO GROUP COMPANY LIMITEDKME2026-03-17
08859149976040DRY PADPHU BAO GROUP COMPANY LIMITEDKME2026-03-17
00850001780353CEGA Innovations, Inc.Cega Innovations, Inc.KME2026-03-12
00850001780377CEGA Innovations, Inc.Cega Innovations, Inc.KME2026-03-12
00748426261284Medline-MicrotekMicrotek Medical LLCKME2026-01-28
00810180842440Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, UniversalDynarex CorporationKME2026-01-05
00850056748230FORWARD APLS Emergency BlanketINTEGRATED MEDCRAFT LLCKME2025-11-25
M68904106020HI-VIS Emergency BlanketSafeguard US Operating, LLCKME2025-09-15
00304040193150Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
00850056748483FORWARD HEAT - Emergency BlanketINTEGRATED MEDCRAFT LLCKME2025-09-02
06979032640093GOBENHUZHOU JUNDA INDUSTRY CO., LTD.KME2025-08-26
50192253014424CARDINAL HEALTHCardinal Health 200, LLCKME2025-08-19
00850061859785GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859792GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859808GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859815GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859822GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859839GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859846GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
00850061859853GCB Medical SupplyGCB MEDICAL LLCKME2025-07-23
16975675788564RESCUE ESSENTIALSEMSRUN GROUPKME2025-07-18
06931918194168AllesetGRI Medical & Electronic Technology Co., Ltd.KME2025-06-21
06931918129818HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2025-06-20
00616784134420DynaCare Disposable Underpads, Compressed Packaging, Absorbent Fluff Fill Dynarex CorporationKME2025-06-10
08938504806793Pinnakle Moderate UnderpadPHU BAO GROUP COMPANY LIMITEDKME2025-05-30
20889483602918AirLife™AirLife Finland OyKME2025-04-17
20889483602925AirLife™AirLife Finland OyKME2025-04-17
20889483602932AirLife™AirLife Finland OyKME2025-04-17
20889483602949AirLife™AirLife Finland OyKME2025-04-17