FDA.reportPublic FDA data

ASEPT®

Primary DI
04046964317415
Brand
ASEPT®
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
622286
Catalog number
622286
Device description
ASEPT DRAINAGE LINE SET
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093307000ASEPT PLEURAL DRAINAGE SYSTEMPfm Medical, Inc.2009-11-06DWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964317415PrimaryGS10
04046964317385Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964317415040469643174154046964317415
04046964317385040469643173854046964317385

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). 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
10
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
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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