SmartStack
FDA UDIEUDAMEDClass I (US FDA UDI)
by Maxtec, Inc.
Identity
- Trade Name
- SmartStack with Dual Tank Holder Bundle EUDAMEDSmartStack FDA UDI
- Generic Name
- Freestanding/bed-attached intravenous pole FDA UDI
- Device Name
- Smart Stack IV Pole Stand & Smart Stack Equipment Stand EUDAMEDSmartStack Bundle with Dual Tank Holder FDA UDI
- Model / Reference
- Smart Stack Premium Single EUDAMEDR100P90-001 EUDAMEDBundle FDA UDI
- Description
- SmartStack Bundle with Dual Tank Holder FDA UDI
Identifiers
- Catalog Number
- R100P90-001 FDA UDI
- Primary DI / UDI-DI
- 00817770022220 EUDAMEDFDA UDI
- Basic UDI-DI
- 081777002Smartstack68 EUDAMED
- Direct Marketing DI
- 00817770022220 EUDAMED
- FDA Product Code
- FOX FDA UDI
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Freestanding/bed-attached intravenous pole FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6990 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Freestanding/bed-attached intravenous pole
SmartStack by Maxtec, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maxtec, Inc.
Sources (2)
- FDA UDI 91087ea2-bccc-4c49-a8b8-b7b9e6d6398c 34 fields · synced Jun 19, 2026
- EUDAMED d272ae3d-2330-425e-8d51-c9ad95d7b28f 61 fields · synced Jun 19, 2026