FDA.reportPublic FDA data

Aspira®

Primary DI
10884450620547
Brand
Aspira®
Company
Merit Medical Systems, Inc.
Model
B
Catalog number
4992208
Published
2026-02-27
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

Product Codes#

Code, Name table
CodeName
PNGPeritoneal, drainage catheter for refractory ascites, long-term indwelling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term IndwellingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450620547PackageGS11In Commercial Distribution
00884450620540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445062054710884450620547
00884450620540008844506205408844506205400884450620540

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450485651Merit Medical®Initial ReleaseK04-00404B2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02
00884450435403Merit Medical®Initial ReleaseK09-11196A2026-06-02
00884450457511C2 CryoBalloon™AFG-10242026-06-02
00884450457528C2 CryoBalloon™AFG-10282026-06-02
00884450457566C2 CryoBalloon™AFG-10552026-06-02
00884450457573C2 CryoBalloon™AFG-10562026-06-02
00884450467183Merit Medical®Initial ReleaseK10T-06193A2026-06-02
00884450474549Merit Medical®Initial ReleaseK09-134782026-06-02
00884450474556Merit Medical®Initial ReleaseK09-134792026-06-02
00884450474563Merit Medical®Initial ReleaseK09-136162026-06-02
00884450589977SplashWire™Initial ReleaseMSWSTFA35150LT2026-06-02
00884450794760DuraMax®AH7871030290412026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450620526Aspira®Merit Medical Systems, Inc.PNG2026-02-27
00884450620540Aspira®Merit Medical Systems, Inc.PNG2026-02-27
10884450620523Aspira®Merit Medical Systems, Inc.PNG2026-02-27
00884450620601Aspira®Merit Medical Systems, Inc.PNG2025-10-02
10884450620608Aspira®Merit Medical Systems, Inc.PNG2025-10-02
00860009032200Passio Redressing KitBearpac Medical, LLCPNG2025-08-08
00884450620557Aspira®Merit Medical Systems, Inc.PNG2025-06-03
10884450620554Aspira®Merit Medical Systems, Inc.PNG2025-06-03
00884450544969Aspira®Merit Medical Systems, Inc.PNG2025-04-21
10884450544966Aspira®Merit Medical Systems, Inc.PNG2025-04-21
00884450751305Aspira®Merit Medical Systems, Inc.PNG2025-04-21
00801741230608PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
00801741230615PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
00801741230639PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
10801741230605PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
10801741230612PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
10801741230636PeritXBard Peripheral Vascular, Inc.PNG2025-01-23
00884450544952Aspira®Merit Medical Systems, Inc.PNG2024-03-06
10884450544959Aspira®Merit Medical Systems, Inc.PNG2024-03-06
00086000903220Passio Redressing KitBearpac Medical, LLCPNG2024-02-29
00860099001322Passio Pump Drainage SystemBearpac Medical, LLCPNG2023-08-11
00884450534311Aspira®Merit Medical Systems, Inc.PNG2022-12-07
10884450534318Aspira®Merit Medical Systems, Inc.PNG2022-12-07
00884450534304Aspira®Merit Medical Systems, Inc.PNG2022-03-16
10884450534301Aspira®Merit Medical Systems, Inc.PNG2022-03-16
10885403500831PeritXCAREFUSION 2200, INCPNG2021-03-09
10885403500848PeritXCAREFUSION 2200, INCPNG2021-03-09
10885403502040PeritXCAREFUSION 2200, INCPNG2021-03-09
10885403502378N/ACAREFUSION 2200, INCPNG2021-03-09
10885403502385N/ACAREFUSION 2200, INCPNG2021-03-09