FDA.reportPublic FDA data

Medline

Primary DI
10080196759620
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJAAPI1000S
Catalog number
DYNJAAPI1000S
Device description
1000ML,PRESSURE INFUSER W/STOPCOCK
Published
2023-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
40080196759621PackageGS112In Commercial Distribution
10080196759620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019675962140080196759621
1008019675962010080196759620

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry. Keep away from sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884389177686MEDLINEMDSMPHS4MDSMPHS42021-04-23
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536933705BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933712BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933729BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933736BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933743BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933750BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933767BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00199536933774BluelineTransparent Supply Solutions Ltd.KZD2026-05-15
00810132043789HCSConcordance Healthcare Solutions LLCKZD2026-05-13
00810132043796HCSConcordance Healthcare Solutions LLCKZD2026-05-13
00810132043680HCSConcordance Healthcare Solutions LLCKZD2025-10-23
00810132043697HCSConcordance Healthcare Solutions LLCKZD2025-10-23
00810132043703HCSConcordance Healthcare Solutions LLCKZD2025-10-23
10889483600962Vital Signs™AIRLIFEKZD2025-07-31
10889483600986Vital Signs™AIRLIFEKZD2025-07-31
10889483600993Vital Signs™AIRLIFEKZD2025-07-31
10889483601013Vital Signs™AIRLIFEKZD2025-07-31
10889483601037Vital Signs™AIRLIFEKZD2025-07-31
10889483642368Vital Signs™SUNMED, LLCKZD2025-07-31
10889483642382Vital Signs™SUNMED, LLCKZD2025-07-31
10889483642405Vital Signs™SUNMED, LLCKZD2025-07-31
00816317024277Medline Pressure Infuser Bag 1000mlRENU MEDICAL, INCKZD2024-12-02
00816317024284Medline Pressure Infuser Bag 500mlRENU MEDICAL, INCKZD2024-12-02
00811220035488PremierProPRESTIGE AMERITECH, LTD.KZD2024-10-28
00811220035501PremierProPRESTIGE AMERITECH, LTD.KZD2024-10-28
10889483230770InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
10889483230787InfuseOneETHOX MEDICAL, LLCKZD2024-07-01
10193489033106MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
10193489033113MedlineMEDLINE INDUSTRIES, INC.KZD2024-01-16
10197344020508MedlineMEDLINE INDUSTRIES, INC.KZD2023-12-21