Identity
- Trade Name
- A.T.S.® EUDAMEDZIMMER® A.T.S.® FDA UDI
- Generic Name
- Freestanding/bed-attached intravenous pole FDA UDI
- Device Name
- DHF186 - IV Pole and Roll Stand EUDAMED
- Model / Reference
- 60190900100 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 60190900100 FDA UDI
- Primary DI / UDI-DI
- 00889024589452 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024-ZB003021-EU EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Freestanding/bed-attached intravenous pole FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5910 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tourniquet cuff, single-use
A.t.s.® by Zimmer Surgical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 889024-ZB003021-EU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zimmer Surgical, Inc.
- EUDAMED SRN
- US-MF-000001150
- Authorised Representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Sources (2)
- EUDAMED 8851ea21-e7ac-484d-bba9-acec40330365 61 fields · synced Jul 25, 2026
- FDA UDI 911721e0-bc8b-4fe0-afc3-243568defe41 34 fields · synced May 30, 2026