FDA.reportPublic FDA data

ASEPT®

Primary DI
04046964317491
Brand
ASEPT®
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
622288
Catalog number
622288
Device description
ASEPT REPLACEMENT VALVE
Published
2016-08-09
Public version status
Update
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
DWMAPPARATUS, SUCTION, PATIENT CARE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWMApparatus, Suction, Patient CareCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964317491PrimaryGS10
04046964317477Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964317491040469643174914046964317491
04046964317477040469643174774046964317477

GMDN Terms#

Term, Definition table
TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00KEEP DRY
Special Storage Condition, Specify00ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Store at room temp

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
Device count
5
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964309809Micro-Access Elite®6133406133402016-08-09
04046964309823Micro-Access Elite®6133416133412016-08-09
04046964309847Micro-Access Elite®6133426133422016-08-09
04046964309861Micro-Access Elite®6133436133432016-08-09
04046964309885Micro-Access Elite®6133446133442016-08-09
04046964309908Micro-Access Elite®6133456133452016-08-09
04046964309922Micro-Access Elite®6133466133462016-08-09
04046964309946Micro-Access Elite®6133476133472016-08-09
04046964309960Micro-Access Elite®6133486133482016-08-09
04046964309977Micro-Access Elite®6133496133492016-08-09
04046964310003Micro-Access Elite®6133506133502016-08-09
04046964310027Micro-Access Elite®6133516133512016-08-09
04046964310041Micro-Access Elite®6133526133522016-08-09
04046964310065Micro-Access Elite®6133536133532016-08-09
04046964310089Micro-Access Elite®6133546133542016-08-09
04046964310102Micro-Access Elite®6133556133552016-08-09
04046964310126Micro-Access Elite®6133566133562016-08-09
04046964310140Micro-Access Elite®6133576133572016-08-09
04046964310164Micro-Access Elite®6133586133582016-08-09
04046964310188Micro-Access Elite®6133596133592016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450772515Aspira®Merit Medical Systems, Inc.DWM2026-03-27
00884450620588Aspira®Merit Medical Systems, Inc.DWM2026-03-05
10884450620585Aspira®Merit Medical Systems, Inc.DWM2026-03-05
00884450620564Aspira®Merit Medical Systems, Inc.DWM2026-02-27
00884450620595Aspira®Merit Medical Systems, Inc.DWM2026-02-27
10884450620561Aspira®Merit Medical Systems, Inc.DWM2026-02-27
10884450620592Aspira®Merit Medical Systems, Inc.DWM2026-02-27
00884450620649Aspira®Merit Medical Systems, Inc.DWM2025-10-21
10884450620646Aspira®Merit Medical Systems, Inc.DWM2025-10-21
00860009032200Passio Redressing KitBearpac Medical, LLCDWM2025-08-08
00860099001315Passio Handheld Control UnitBearpac Medical, LLCDWM2025-07-07
00884450620625Aspira®Merit Medical Systems, Inc.DWM2025-05-29
10884450620622Aspira®Merit Medical Systems, Inc.DWM2025-05-29
00884450620632Aspira®Merit Medical Systems, Inc.DWM2025-01-23
10884450620639Aspira®Merit Medical Systems, Inc.DWM2025-01-23
00860099001391Passio Valve Cap KitBearpac Medical, LLCDWM2024-02-29
00086000903220Passio Redressing KitBearpac Medical, LLCDWM2024-02-29
10860099001398Passio Valve Cap KitBearpac Medical, LLCDWM2024-02-29
00884450544990Aspira®Merit Medical Systems, Inc.DWM2024-01-30
10884450544997Aspira®Merit Medical Systems, Inc.DWM2024-01-30
05055270982643RocketROCKET MEDICAL PLCDWM2023-10-23
05055270982650RocketROCKET MEDICAL PLCDWM2023-10-23
05055270982339RocketROCKET MEDICAL PLCDWM2023-10-20
05055270982346RocketROCKET MEDICAL PLCDWM2023-10-20
00860099001346Passio Catheter Valve Replacement KitBearpac Medical, LLCDWM2023-08-25
00860099001308Passio Disposable Collection SystemBearpac Medical, LLCDWM2023-08-25
10860099001343Passio Catheter Valve Replacement KitBearpac Medical, LLCDWM2023-08-25
00860099001322Passio Pump Drainage SystemBearpac Medical, LLCDWM2023-08-11
00860099001353Passio Adapter KitBearpac Medical, LLCDWM2023-08-11
10885403502378N/ACAREFUSION 2200, INCDWM2021-03-09