Identity
- Trade Name
- Foam Swab 20 Pack FDA UDI
- Generic Name
- Gastrostomy aspiration system gravity set FDA UDI
- Device Name
- Foam Swab 20 Pack FDA UDI
- Model / Reference
- 100-0019 FDA UDI
- Description
- Foam Swab 20 Pack FDA UDI
Identifiers
- Catalog Number
- 100-0019 FDA UDI
- Primary DI / UDI-DI
- 10857808005228 FDA UDI
- PMA Number
- P150024 FDA UDI
- FDA Product Code
- OYF FDA UDI
- GMDN Term
- Gastrostomy aspiration system gravity set FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Foam Swab 20 Pack by Aspire Bariatrics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P150024 also covers:
- AspireAssist A-Tube Kit — ASPIRE BARIATRICS, INC.
- AspireAssist A-Tube Kit — ASPIRE BARIATRICS, INC.
- AspireAssist A-Tube Kit — ASPIRE BARIATRICS, INC.
- AspireAssist A-Tube Kit — ASPIRE BARIATRICS, INC.
- AspireAssist A-Tube Pack — ASPIRE BARIATRICS, INC.
- AspireAssist Carry Bag — ASPIRE BARIATRICS, INC.
- AspireAssist Companion, Blue-LANG A — ASPIRE BARIATRICS, INC.
- AspireAssist Companion, Blue-LANG B — ASPIRE BARIATRICS, INC.
- AspireAssist Companion, Blue-LANG C — ASPIRE BARIATRICS, INC.
- AspireAssist Companion, Blue-US — ASPIRE BARIATRICS, INC.
- AspireAssist Companion, Magenta-LANG A — ASPIRE BARIATRICS, INC.
- AspireAssist Companion, Magenta-LANG B — ASPIRE BARIATRICS, INC.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Aspire Bariatrics, Inc.
Sources (1)
- FDA UDI 0cd96962-4148-4941-bbef-1117212e4c54 37 fields · synced May 31, 2026