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Dialy-Nate
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 4000517Ref 4000537Ref 4000527Ref 4000547Ref 4000557Ref 4000567
Identity
- Trade Name
- DIALY-NATE EUDAMEDFDA UDI
- Generic Name
- Peritoneal dialysis system tubing set FDA UDI
- Device Name
- Dialy-Nate EUDAMEDSET, Peritoneal Dialysis Set for Neonates FDA UDISET W/ UNBONDED TUBING FOR HEATING, Peritoneal Dialysis Set for Neonates FDA UDISET W/ LUER LOCKING CONNECTIONS AND HEATING COIL, Peritoneal Dialysis Set for Neonates FDA UDISET W/ LUER LOCKING CONNECTIONS, W/ UNBONDED TUBING FOR HEATING, Peritoneal Dialysis Set for Neonates FDA UDISET, SINGLE USE / LOW VOLUME, Peritoneal Dialysis Set for Neonates FDA UDISET W/ ADDITIONAL BURETTE ASSEMBLY, Peritoneal Dialysis Set for Neonates FDA UDISET WITH LUER CONNECTORS AND A 4-WAY STOPCOCK, Peritoneal Dialysis Set for Neonates FDA UDI
- Model / Reference
- 4000517 EUDAMED4000537 EUDAMED4000527 EUDAMED4000547 EUDAMED4000557 EUDAMED4000567 EUDAMEDSet FDA UDI
- Description
- SET, Peritoneal Dialysis Set for Neonates FDA UDISET W/ UNBONDED TUBING FOR HEATING, Peritoneal Dialysis Set for Neonates FDA UDISET W/ LUER LOCKING CONNECTIONS AND HEATING COIL, Peritoneal Dialysis Set for Neonates FDA UDISET W/ LUER LOCKING CONNECTIONS, W/ UNBONDED TUBING FOR HEATING, Peritoneal Dialysis Set for Neonates FDA UDISET, SINGLE USE / LOW VOLUME, Peritoneal Dialysis Set for Neonates FDA UDISET W/ ADDITIONAL BURETTE ASSEMBLY, Peritoneal Dialysis Set for Neonates FDA UDISET WITH LUER CONNECTORS AND A 4-WAY STOPCOCK, Peritoneal Dialysis Set for Neonates FDA UDI
Identifiers
- Catalog Number
- 4000507 FDA UDI4000517 FDA UDI4000527 FDA UDI4000537 FDA UDI4000557 FDA UDI4000547 FDA UDI4000567 FDA UDI
- Primary DI / UDI-DI
- H67140005170 EUDAMEDFDA UDIH67140005270 EUDAMEDFDA UDIH67140005370 EUDAMEDFDA UDIH67140005570 EUDAMEDFDA UDIH67140005470 EUDAMEDFDA UDIH67140005670 EUDAMEDFDA UDIH67140005070 FDA UDI
- Basic UDI-DI
- ++H671CE018IN6 EUDAMED
- FDA Product Code
- FKO FDA UDI
- EMDN Code
- F900101 PERITONEAL DIALYSIS CATHETERS AND KITS EUDAMED
- GMDN Term
- Peritoneal dialysis system tubing set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5630 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peritoneal dialysis system tubing set
Dialy-Nate by Utah Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (13)
- FDA UDI eb21a880-b837-4d10-9395-678f58a3a0d0 35 fields · synced Sep 18, 2026
- FDA UDI c5c48ef5-a0be-4934-b337-1ca355b34fc5 35 fields · synced May 30, 2026
- FDA UDI 8b42f48c-3a83-48fe-8eb2-90cee6cf9ba2 35 fields · synced May 30, 2026
- FDA UDI 3d02e1d0-4233-4267-8b1b-807996609268 35 fields · synced May 30, 2026
- FDA UDI 8cf735c0-fb86-4efe-85f5-361e3305105d 35 fields · synced May 30, 2026
- FDA UDI 2789d883-31e8-406d-b456-7a2bf9f7209d 35 fields · synced May 30, 2026
- FDA UDI a364943a-4c7e-4cb4-80bf-1d1f2416ac9d 35 fields · synced May 30, 2026
- EUDAMED d1652635-bcdc-4008-948f-ed352e4be2ff 61 fields · synced Jun 20, 2026
- EUDAMED 80cfa6cf-8d47-437f-a0a4-dd9dea25b2ab 61 fields · synced Jul 8, 2026
- EUDAMED e16b4f15-e5ce-473f-b7ef-3dfaa655fe2f 61 fields · synced Jul 9, 2026
- EUDAMED 20ceb47b-0027-4b47-995f-d1e557ae69be 61 fields · synced Jul 18, 2026
- EUDAMED 53cfc02c-dc36-419c-a038-bb65a77d0184 61 fields · synced Jul 24, 2026
- EUDAMED 3db83fd0-aac2-458b-8c41-6f1e9fa6165b 61 fields · synced Sep 18, 2026