Identity
- Trade Name
- AirTight Control Syringes FDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Model / Reference
- 10ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947358516019 FDA UDI
- 510(k) Number
- K160190 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Angiographic syringe 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
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: Angiographic syringe
AirTight Control Syringes by Sunny Medical Device (Shenzhen) Co.Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Angiographic syringe.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- NAMIC — NAVILYST MEDICAL, INC. · Class II
- Antmed — ShenZhen Antmed Co., Ltd · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Inject8™ — Merit Medical Systems, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunny Medical Device (Shenzhen) Co.Ltd
Sources (1)
- FDA UDI bcfc300c-0c38-426d-963c-2bde455295dc 33 fields · synced Jul 4, 2026