Identity
- Trade Name
- Infusion Set for Single Use FDA UDI
- Generic Name
- Electronic gravity infusion controller administration set FDA UDI
- Model / Reference
- AD0102 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970440020026 FDA UDI
- 510(k) Number
- K162601 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Electronic gravity infusion controller administration set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Electronic gravity infusion controller administration set
Infusion Set for Single Use by Shinva Ande Healthcare Apparatus Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162601 also covers:
- Extension Set Minibore — Merit Pharmaceutical
- Extension Set Regular Bore — Merit Pharmaceutical
- Extension Set Regular Bore Needlefree — Merit Pharmaceutical
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus Co., Ltd.
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus Co., Ltd.
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus Co., Ltd.
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus Co., Ltd.
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus Co., Ltd.
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus Co., Ltd.
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus Co., Ltd.
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus Co., Ltd.
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus 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 |
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Manufacturer
- Manufacturer
- Shinva Ande Healthcare Apparatus Co., Ltd.
Sources (1)
- FDA UDI 8ccad693-52ee-4f0b-b886-e76da1a4b331 33 fields · synced May 31, 2026