Identity
- Trade Name
- SmartStack IV Stand Kit EUDAMEDSmartStack FDA UDI
- Generic Name
- Freestanding/bed-attached intravenous pole FDA UDI
- Device Name
- Smart Stack IV Pole Stand & Smart Stack Equipment Stand EUDAMEDSmartStack IV Stand Kit FDA UDI
- Model / Reference
- R10p49-010 EUDAMEDIV Stand FDA UDI
- Description
- SmartStack IV Stand Kit FDA UDI
Identifiers
- Catalog Number
- R100P49-010 FDA UDI
- Primary DI / UDI-DI
- 00817770025795 EUDAMEDFDA UDI
- Basic UDI-DI
- 081777002Smartstack68 EUDAMED
- Direct Marketing DI
- 00817770025795 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Freestanding/bed-attached intravenous pole
SmartStack by Maxtec, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Freestanding/bed-attached intravenous pole.
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- B-Braun — PRYOR PRODUCTS · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 d319b710-b43e-4509-8783-ee0d1dadb711 34 fields · synced Jul 8, 2026
- EUDAMED ab2a8238-179f-4c78-be8f-08f2a446c7f1 61 fields · synced Jul 8, 2026