Identity
- Trade Name
- ASEPT FDA UDI
- Generic Name
- Closed-wound drainage reservoir suction bulb FDA UDI
- Device Name
- ASEPT 600mL Starter Kit FDA UDI
- Model / Reference
- M7080 FDA UDI
- Description
- ASEPT 600mL Starter Kit FDA UDI
Identifiers
- Catalog Number
- M7080 FDA UDI
- Primary DI / UDI-DI
- 00813623016972 FDA UDI
- FDA Product Code
- KDQ FDA UDI
- GMDN Term
- Closed-wound drainage reservoir suction bulb FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 drainage reservoir suction bulb
Asept by Pfm Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound drainage reservoir suction bulb.
- Axiom® CWV — AXIOM MEDICAL, INCORPORATED · Class I
- ASEPT — PFM MEDICAL INCORPORATED · Class II
- ASEPT — PFM MEDICAL INCORPORATED · Class II
- ASEPT — PFM MEDICAL INCORPORATED · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pfm Medical Incorporated
Sources (1)
- FDA UDI 83c06f71-3351-4b7c-bc94-707150c6547c 35 fields · synced Jun 1, 2026