FDA.reportPublic FDA data

NA

Primary DI
04046964186981
Brand
NA
Company
B. BRAUN MEDICAL INC.
Model
N5062
Catalog number
N5062
Device description
Pressure Administration Cuff for EXCE L IV Container
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04046964186981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964186981040469641869814046964186981

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955672370Design Options®5606805606802026-05-24
04046955850839Omnifix®4616025V-024616025V-022026-03-08
04046955897186Design Options®5703495703492026-03-02
04045928020866Design Options®5521505521502026-02-03
04046955900534Perifix®5520475520472026-02-03
04046955900855Design Options®5555255555252026-02-03
04046955901197Combined Spinal & Epidural5301535301532026-02-03
04045928020200Design Options®5301855301852020-04-24
04046955966165Design Options®5703605703602026-01-25
04046955086832Extension Set4904964904962017-10-28
04046964296710Extension Set4565214565212016-09-23
04046964525728Extension Set4903164903162016-09-23
04046964296697Extension Set4565204565202016-09-23
04046964183218Perifix®4150004150002016-09-23
04046964941054PERIFIX™3391603391602016-10-24
04046964332333VENA TECH6107716107712017-01-18
04046955672028Design Options®5606765606762025-12-22
04046955745753Introcan Safety ® 24242001-024242001-022025-12-19
04046955745838Introcan Safety ® 24242003-024242003-022025-12-19
04046955745913Introcan Safety ® 24242005-024242005-022025-12-19

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