Identity
- Trade Name
- SECURE® FDA UDI
- Generic Name
- Intravenous administration bag/bottle FDA UDI
- Device Name
- EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors FDA UDI
- Model / Reference
- 66630 FDA UDI
- Description
- EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors FDA UDI
Identifiers
- Catalog Number
- 66630 FDA UDI
- Primary DI / UDI-DI
- 00812496011503 FDA UDI
- 510(k) Number
- K960581 FDA UDI
- FDA Product Code
- KPE FDA UDI
- GMDN Term
- Intravenous administration bag/bottle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5025 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3000 Milliliter FDA UDI
Category: Intravenous administration bag/bottle
Secure® by Metrix Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intravenous administration bag/bottle.
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- Parenteral nutrition bag — VALMED SRL · Class IIa
- Parenteral nutrition bag — VALMED SRL · Class IIa
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- EVA TPN Bags — Valmed Corp. · Class II
- Parenteral nutrition bag — VALMED SRL · Class IIa
Cleared under the same submission
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
- Metrix Company, The
Sources (1)
- FDA UDI ba12b8e9-093f-4d08-86a1-684498b77a61 37 fields · synced May 30, 2026