Identity
- Trade Name
- Y-Piece FDA UDI
- Generic Name
- Electronic gravity infusion controller administration set FDA UDI
- Model / Reference
- 9021P1164 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627825008204 FDA UDI
- FDA Product Code
- FEN FDA UDI
- GMDN Term
- Electronic gravity infusion controller administration set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1620 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Electronic gravity infusion controller administration set
Y-Piece by Laborie Medical Technologies Canada ULC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electronic gravity infusion controller administration set.
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- Primrose Medical, Inc — PRIMROSE MEDICAL, INC. · Class II
- All-Med, Inc. — ALL-MED INC · Class II
- All-Med, Inc. — ALL-MED INC · Class II
- Infusion Set for Single Use — Shinva Ande Healthcare Apparatus Co., Ltd. · 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
- Laborie Medical Technologies Canada ULC
Sources (1)
- FDA UDI 2a8f699d-e172-4317-b5ae-8d69162601b1 32 fields · synced Jun 8, 2026