FDA.reportPublic FDA data

N/A

Primary DI
57613327500108
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
PIB1000
Catalog number
PIB1000
Device description
Merit Medical Pressure Infusor Bag, 1000 mL
Published
2019-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
57613327500108PackageGS112In Commercial Distribution
10817357020660PreviousGS10
07613327500103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332750010857613327500108
1081735702066010817357020660
07613327500103076133275001037613327500103

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1000Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327679571N/AD128622D1286222025-05-21
07613327666762N/A9898031450519898031450512025-02-24
07613327666786N/A9898031990719898031990712025-02-24
57613327666804N/A9898031975119898031975112025-02-24
07613327666939N/A9898032111719898032111712025-02-24
57613327664084Philips Healthcare014R014R2025-02-11
57613327664091Philips Healthcare85900P85900P2025-02-11
57613327664107Philips Healthcare85900PST85900PST2025-02-11
57613327664114Philips Healthcare88901889012025-02-11
57613327383923N/AN/A5921-024-145RP2019-08-04
57613327383930N/AN/A5921-030-135RP2019-08-04
57613327383947N/AN/A5921-030-236RP2019-08-04

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