Identity
- Trade Name
- Demax FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Model / Reference
- DPBD52 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06943718223337 FDA UDI
- 510(k) Number
- K140943 FDA UDI
- FDA Product Code
- MAV FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
Yes
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
Yes
FDA UDI
Category: Catheter/overtube balloon inflator, single-use
Demax by Beijing Demax Medical Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Catheter/overtube balloon inflator, single-use.
- basixCOMPAK™ — Merit Medical Systems, Inc. · Class II
- Monarch® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K140943 also covers:
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
- Demax — Beijing Demax Medical Technology Co., Ltd
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Demax Medical Technology Co., Ltd
Sources (1)
- FDA UDI 2eb5eeab-d946-4834-a942-1fbe38046f63 33 fields · synced May 30, 2026