FDA.report

Aspira®

Primary DI
10884450544997
Brand
Aspira®
Company
Merit Medical Systems, Inc.
Model
00884450544990
Catalog number
4992504
Published
2024-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DWMAPPARATUS, SUCTION, PATIENT CARE

Product Code Classifications

CodeDeviceSpecialtyClass
DWMApparatus, Suction, Patient CareCardiovascular2

Premarket Submissions

SubmissionSupplement
K212696000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K212696000Aspira Pleural Drainage SystemMerit Medical Systems, Inc.2023-03-03DWM

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450544997PackageGS11In Commercial Distribution
00884450544990PrimaryGS10

GMDN Terms

TermDefinition
Pleural/peritoneal drainage catheterization kitA collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, 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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24
10884450845223Merit Medical®D3339-312026-03-24
10884450027339Merit Medical®Initial ReleaseK04-01029A2026-03-20
10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
20884450164918Merit Medical®Initial ReleaseK09-12174B2026-03-21
10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
10884450430788Merit Medical®Initial ReleaseK10-05773A2026-03-21
10884450430856Merit Medical®Initial ReleaseK09-04213A2026-03-21
10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450620585Aspira®Merit Medical Systems, Inc.DWM2026-03-05
10884450620561Aspira®Merit Medical Systems, Inc.DWM2026-02-27
10884450620592Aspira®Merit Medical Systems, Inc.DWM2026-02-27
10884450620646Aspira®Merit Medical Systems, Inc.DWM2025-10-21
00860009032200Passio Redressing KitBearpac Medical, LLCDWM2025-08-08
00860099001315Passio Handheld Control UnitBearpac Medical, LLCDWM2025-07-07
10884450620622Aspira®Merit Medical Systems, Inc.DWM2025-05-29
10884450620639Aspira®Merit Medical Systems, Inc.DWM2025-01-23
00086000903220Passio Redressing KitBearpac Medical, LLCDWM2024-02-29
10860099001398Passio Valve Cap KitBearpac Medical, LLCDWM2024-02-29
05055270982650RocketROCKET MEDICAL PLCDWM2023-10-23
05055270982346RocketROCKET MEDICAL PLCDWM2023-10-20
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
50885403502383N/ACAREFUSION 2200, INCDWM2021-03-09
50885403502406N/ACAREFUSION 2200, INCDWM2021-03-09
50885403502413N/ACAREFUSION 2200, INCDWM2021-03-09
10884450394929Aspira®Merit Medical Systems, Inc.DWM2020-07-24
10884450394967Aspira®Merit Medical Systems, Inc.DWM2020-07-14
20884450394971Aspira®Merit Medical Systems, Inc.DWM2020-03-20
10884450394936Aspira®Merit Medical Systems, Inc.DWM2020-02-13
10884450394950Aspira®Merit Medical Systems, Inc.DWM2020-02-04
10884450398170Aspira®Merit Medical Systems, Inc.DWM2019-12-30
10884450394912Aspira®Merit Medical Systems, Inc.DWM2019-12-05
10884450394943Aspira®Merit Medical Systems, Inc.DWM2019-11-27
10884450394981Aspira®Merit Medical Systems, Inc.DWM2019-11-14
20884450394865Aspira®Merit Medical Systems, Inc.DWM2019-09-23
20813623017058ASEPTPFM MEDICAL INCORPORATEDDWM2019-03-31