Identity
- Trade Name
- AspireAssist Emergency Clamp FDA UDI
- Generic Name
- Gastrostomy aspiration system gravity set FDA UDI
- Device Name
- Emergency Clamp FDA UDI
- Model / Reference
- 100-0029 FDA UDI
- Description
- Emergency Clamp FDA UDI
Identifiers
- Catalog Number
- 100-0029 FDA UDI
- Primary DI / UDI-DI
- 10857808005259 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastrostomy aspiration system gravity set
AspireAssist Emergency Clamp by Aspire Bariatrics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrostomy aspiration system gravity set.
- AspireAssist Lanyard — ASPIRE BARIATRICS, INC. · Class III
- AspireAssist Connector-US — ASPIRE BARIATRICS, INC. · Class III
- AspireAssist Starter Kit, Magenta-LANG B — ASPIRE BARIATRICS, INC. · Class III
- AspireAssist First Year Kit, Blue-LANG B — ASPIRE BARIATRICS, INC. · Class III
- AspireAssist Connector-LANG C — ASPIRE BARIATRICS, INC. · Class III
- AspireAssist Starter Kit, Blue-US — ASPIRE BARIATRICS, INC. · Class III
- AspireAssist First Year Kit, Magenta-LANG C — ASPIRE BARIATRICS, INC. · Class III
- AspireAssist Skin-Port Sleeve, Multipack (5x)-LANG B — ASPIRE BARIATRICS, INC. · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aspire Bariatrics, Inc.
Sources (1)
- FDA UDI 3c930a03-a365-48f5-ad63-3f86cc43bfc1 36 fields · synced May 30, 2026