FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450331986
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450331989
Catalog number
PIB3000
Published
2018-07-30
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
10884450331986PackageGS16In Commercial Distribution
20884450331983PackageGS14In Commercial Distribution
00884450331989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445033198610884450331986
2088445033198320884450331983
00884450331989008844503319898844503319890884450331989

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pressure infusor, manualA manually-operated device designed to increase the rate of an intravenous (IV) solution given to a patient by applying pressure directly to the infusion bag. There are two main designs: 1) a flexible bag made of textile or clear plastic with a pocket to hold the infusion bag and an inflatable pressure chamber or cuff that, when inflated, applies the desired pressure -- included is a squeeze bulb for the operator to create the pressure, a line clamp, and a pressure gauge; and 2) a design similar to the first, but where the pressure is created typically using a mechanical screw or spring mechanism. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

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