FDA.reportPublic FDA data

Aspira®

Primary DI
00884450772515
Brand
Aspira®
Company
Merit Medical Systems, Inc.
Model
A
Catalog number
4992504
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
10884450772512PackageGS11In Commercial Distribution
20884450772519PackageGS11In Commercial Distribution
00884450772515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445077251210884450772512
2088445077251920884450772519
00884450772515008844507725158844507725150884450772515

GMDN Terms#

Term, Definition table
TermDefinition
Pleural/peritoneal drainage catheterization kit, non-medicatedA collection of non-powered devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions (e.g., haemothorax, empyema, ascites), other fluids, and/or air; some types are additionally intended for infusion of fluids/materials into the pleural/peritoneal space. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller), non-dedicated catheterization support devices (e.g., dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
184763290
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10885403502385N/ACAREFUSION 2200, INCDWM2021-03-09