FDA UDI
In Commercial Distribution
🇺🇸 United States
Aspira®
DI: 00884450751305
·
Model: A
·
Merit Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aspira®
- Primary DI
- 00884450751305
- Version / Model
- A
- Catalog Number
- 4992204
- Company Name
- Merit Medical Systems, Inc.
- Labeler DUNS
- 184763290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-21
- Public Version
- 2
- Public Version Date
- 2025-12-15
- Public Version Status
- Update
- Public Device Record Key
- 96f0ac2a-3303-4919-b925-a74e90401706
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PNG | Peritoneal, drainage catheter for refractory ascites, long-term indwelling | Gastroenterology, Urology | 876.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47797 | Pleural/peritoneal drainage catheterization kit, non-medicated | A 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884450751305 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | French Size (F)-15.5F |