FDA.reportPublic FDA data

ASP MEDICAL

Primary DI
00840216102682
Brand
ASP MEDICAL
Company
Asp Global, LLC
Model
IAA502
Device description
BAG, PRESSURE INFUSER, 1000ML CLEAR BACK
Published
2022-07-15
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
KZDInfusor, Pressure, For I.V. Bags

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZDInfusor, Pressure, For I.V. BagsGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216102682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216102682008402161026828402161026820840216102682

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pressure infusor, manual, single-useA manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. 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
30889483600966Vital Signs™AIRLIFEKZD2025-07-31
30889483600980Vital Signs™AIRLIFEKZD2025-07-31
30889483600997Vital Signs™AIRLIFEKZD2025-07-31
30889483601017Vital Signs™AIRLIFEKZD2025-07-31
30889483601031Vital Signs™AIRLIFEKZD2025-07-31
30889483642362Vital Signs™SUNMED, LLCKZD2025-07-31
30889483642386Vital Signs™SUNMED, LLCKZD2025-07-31
30889483642409Vital Signs™SUNMED, LLCKZD2025-07-31
10816317024274Medline Pressure Infuser Bag 1000mlRENU MEDICAL, INCKZD2024-12-02
10816317024281Medline Pressure Infuser Bag 500mlRENU MEDICAL, INCKZD2024-12-02
06945040106197CONTECContec Medical Systems Co., Ltd.KZD2024-11-11
00811220035495PremierProSVS LLCKZD2024-10-28
00811220035518PremierProSVS LLCKZD2024-10-28
20889483230777InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
20889483230784InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
04719871892282JBCFOREMOUNT ENTERPRISE CO., LTD.KZD2024-06-28
04719871892299JBCFOREMOUNT ENTERPRISE CO., LTD.KZD2024-06-28
09008247000600automatic pressure infusorBiegler GmbHKZD2024-06-07
06971919460602BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460619BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460626BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460633BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460657BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
06971919460664BieglerNingbo Albert Novosino Co.,Ltd.KZD2024-05-24
10884450777715Merit Medical®Merit Medical Systems, Inc.KZD2024-04-09
10884450777722Merit Medical®Merit Medical Systems, Inc.KZD2024-04-09
10884450777739Merit Medical®Merit Medical Systems, Inc.KZD2024-03-07
20193489033103MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
20193489033110MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
20197344020505MedlineMEDLINE INDUSTRIES, INC.KZD2023-12-21