FDA.reportPublic FDA data

ASEPT

Primary DI
04046955911493
Brand
ASEPT
Company
B. BRAUN MEDICAL INC.
Model
622282
Catalog number
622282
Device description
ASEPT 1000ML BOTTLE STARTER KIT, 4PK
Published
2025-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PXUFluid drainage tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXUFluid Drainage TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955911493PrimaryGS10
04046955911486Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955911493040469559114934046955911493
04046955911486040469559114864046955911486

GMDN Terms#

Term, Definition table
TermDefinition
Wound drainage bagA plastic pouch designed to be attached with an adhesive to the skin around a large wound or fistula and intended to be used as a receptacle for exudate, blood, or other bodily wastes. It is a one-piece device, supplied in a variety of sizes, with a large-area adhesive flange that can be cut to fit closely around a wound, and which may provide some skin protection. It may have a tubular outlet and be connected to a drain system; it does not include accessory devices (i.e., not a kit). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
002397347
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964176982CONTIPLEX®3317063317062016-09-23
04046964176968CONTIPLEX®3317013317012016-09-23
04046964177026CONTIPLEX®3317553317552016-09-23
04046964177040CONTIPLEX®3317563317562016-09-23
04046964177569CONTIPLEX®3321273321272016-09-23
04046964177583CONTIPLEX®3321283321282016-09-23
04046955966288Design Options®5522095522092026-07-26
04046955836383Infusomat®4906554906552024-08-15
04046955836406Infusomat®4906564906562024-08-15
04046955664214B.BRAUN8713142U-998713142U-992026-07-12
04046964182631Infusomat®3620433620432016-09-23
04046964182679Infusomat®3624323624322016-09-23
04046964185922Infusomat®4900374900372016-09-23
04046964186080Infusomat®4901004901002016-09-23
04046964186103Infusomat®4901014901012016-09-23
04046964186141Infusomat®4901044901042016-09-23
04046964186165Infusomat®4901054901052016-09-23
04046964294013Infusomat®3624313624312016-09-23
04046964294570Infusomat®3634193634192016-09-23
04046964294617Infusomat®3634213634212016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708265018024LiNA OperaScope™ Tubing & Drape kitLiNA Medical AGPXU2026-04-03
10198956062894CARDINAL HEALTHCardinal Health 200, LLCPXU2025-05-02
50198956062892CARDINAL HEALTHCardinal Health 200, LLCPXU2025-05-02
10197106485897CARDINAL HEALTHCardinal Health 200, LLCPXU2023-12-27
50197106485895CARDINAL HEALTHCardinal Health 200, LLCPXU2023-12-27
00884450727911Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
00884450727928Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
10884450727918Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
10884450727925Merit Medical®Merit Medical Systems, Inc.PXU2023-11-08
10197106328750CARDINAL HEALTHCardinal Health 200, LLCPXU2023-10-12
50197106328758CARDINAL HEALTHCardinal Health 200, LLCPXU2023-10-12
10197106362990CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-31
50197106362998CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-31
10197106323458CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-06
50197106323456CARDINAL HEALTHCardinal Health 200, LLCPXU2023-07-06
10195594830410CARDINAL HEALTHCardinal Health 200, LLCPXU2022-09-14
50195594830418CARDINAL HEALTHCardinal Health 200, LLCPXU2022-09-14
00860003054949CLR MedicalCLR MedicalPXU2021-11-05
10195594131883CARDINAL HEALTHCardinal Health 200, LLCPXU2021-06-01
50195594131881CARDINAL HEALTHCardinal Health 200, LLCPXU2021-06-01
00884450486061PeriVac™ KitMerit Medical Systems, Inc.PXU2020-12-22
00884450486115PeriVac™ KitMerit Medical Systems, Inc.PXU2020-12-22
10884450486068Merit Medical®Merit Medical Systems, Inc.PXU2020-12-22
10884450486112Merit Medical®Merit Medical Systems, Inc.PXU2020-12-22
05708265012480LiNA OperaScope™ Tubing & Drape kitLina Medical ApSPXU2020-09-04
10888439581379CARDINAL HEALTHCardinal Health 200, LLCPXU2019-09-09
50888439581377CARDINAL HEALTHCardinal Health 200, LLCPXU2019-09-09
10888439448160CARDINAL HEALTHCardinal Health 200, LLCPXU2019-04-29
50888439448168CARDINAL HEALTHCardinal Health 200, LLCPXU2019-04-29
04046955237500ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCPXU2019-04-26