Identity
- Trade Name
- Gastric Balloon Suction Catheter FDA UDI
- Generic Name
- Gastric calibration tube FDA UDI
- Device Name
- Bio Gastric Balloon Suction Catheter FDA UDI
- Model / Reference
- B-2020 FDA UDI
- Description
- Bio Gastric Balloon Suction Catheter FDA UDI
Identifiers
- Catalog Number
- B-2020 FDA UDI
- Primary DI / UDI-DI
- 10811955020039 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Gastric calibration tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Category: Gastric calibration tube
Gastric Balloon Suction Catheter by Apollo Endosurgery — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BOEHRINGER® ViSiGi 3D™ Sleeve Gastrectomy Calibration System, size 36Fr — BOEHRINGER LABORATORIES, LLC · Class II
- Gastric Balloon Suction Catheter — ReShape Lifesciences Inc. · Class II
- GastriSail — Covidien LP · Class II
- ReShape Calibration Tubes™ — ReShape Lifesciences 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 II | Pending data |
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Manufacturer
- Manufacturer
- Apollo Endosurgery
Sources (1)
- FDA UDI 1dfca6bc-c853-4ca6-bc00-83757dc53c33 35 fields · synced Jun 8, 2026