Identity
- Trade Name
- ASEPT Peritoneal Drainage System FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- ASEPT 2,000mL Drainage Bag FDA UDI
- Model / Reference
- M7058 FDA UDI
- Description
- ASEPT 2,000mL Drainage Bag FDA UDI
Identifiers
- Catalog Number
- M7058 FDA UDI
- Primary DI / UDI-DI
- 00813623019102 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Closed-wound/centesis drainage receptacle
ASEPT Peritoneal Drainage System by Pfm Medical Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound/centesis drainage receptacle.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
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- One-Step™ — Merit Medical Systems, Inc. · Class I
- Thoracentesis and Paracentesis Set — Merit Medical Systems, Inc. · Class I
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pfm Medical Incorporated
Sources (1)
- FDA UDI a5d7e151-c8b5-4aef-a7cf-e6f27b027280 35 fields · synced May 30, 2026