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Cmi
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 004CNBRef 004CBRef 101ARef 001CRef 003CB
Identity
- Trade Name
- CMI EUDAMEDFDA UDI
- Generic Name
- Foetal vacuum extraction system cup, single-use FDA UDIFoetal vacuum extraction system, manual, single-use FDA UDI
- Device Name
- CMI Vacuum Delivery Cups EUDAMEDCMI Vacuum Extraction Pump EUDAMEDOBSTETRICAL VACUUM DELIVERY KIT, 60 mm Soft Touch Cup, Tube, Fluid Trap, Natural FDA UDIVacuum Pump, PN 001C, Non-Electrical (Manual), White, Can be EO Gas Sterilized FDA UDIOBSTETRICAL VACUUM DELIVERY KIT, 60 mm Soft Touch Cup, Tube, without Fluid Trap FDA UDIOBSTETRICAL VACUUM DELIVERY KIT, 60 mm Soft Touch Cup, Tube, Fluid Trap, Pink/Blue FDA UDIVacuum Pump, PN 101A, Non-Electrical (Manual), Blue, Can be Autoclaved & EO Gas Sterilized FDA UDI
- Model / Reference
- 004CNB EUDAMED004CB EUDAMED101A EUDAMED001C EUDAMED003CB EUDAMEDVacuum Delivery Cup 60mm FDA UDIVacuum Pump FDA UDI
- Description
- OBSTETRICAL VACUUM DELIVERY KIT, 60 mm Soft Touch Cup, Tube, Fluid Trap, Natural FDA UDIVacuum Pump, PN 001C, Non-Electrical (Manual), White, Can be EO Gas Sterilized FDA UDIOBSTETRICAL VACUUM DELIVERY KIT, 60 mm Soft Touch Cup, Tube, without Fluid Trap FDA UDIOBSTETRICAL VACUUM DELIVERY KIT, 60 mm Soft Touch Cup, Tube, Fluid Trap, Pink/Blue FDA UDIVacuum Pump, PN 101A, Non-Electrical (Manual), Blue, Can be Autoclaved & EO Gas Sterilized FDA UDI
Identifiers
- Catalog Number
- 004CNB FDA UDI001C FDA UDI003CB FDA UDI004CB FDA UDI101A FDA UDI
- Primary DI / UDI-DI
- H671003CB0 EUDAMEDFDA UDIH671004CB0 EUDAMEDFDA UDIH671101A1 EUDAMEDFDA UDI004CNB EUDAMEDH671001C1 EUDAMEDH671004CNB0 FDA UDIH671001C0 FDA UDI
- Basic UDI-DI
- ++H671CE012IIAC4 EUDAMED++H671CE014IMS EUDAMED
- FDA Product Code
- HDB FDA UDI
- EMDN Code
- Z12080301 OBSTETRIC VACUUM EXTRACTORS EUDAMED
- GMDN Term
- Foetal vacuum extraction system cup, single-use FDA UDIFoetal vacuum extraction system, manual, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4340 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA 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 UDIFDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 60 Millimeter FDA UDI
Category: Foetal vacuum extraction system cup, single-use
Cmi by Utah Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Foetal vacuum extraction system cup, single-use.
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- ATMOS S 351 NATAL, 230 V — ATMOS MedizinTechnik GmbH & Co. KG · Class IIa
- Mityvac® — CooperSurgical, Inc. · Class IIa
- Silicone Birth Vac Cup — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
- Silicone Birth Vac Cup — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
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 (10)
- FDA UDI 3e760446-3a7f-443a-9e8d-61734a98a3fa 37 fields · synced Jul 30, 2026
- FDA UDI c13a000e-988b-4848-9464-870aaf6127a5 36 fields · synced May 25, 2026
- FDA UDI 099ac661-fb9f-4fe7-a604-8004acf7ba65 37 fields · synced May 29, 2026
- FDA UDI 1b3d69d0-2944-4006-a059-3e685b0ec56b 37 fields · synced May 30, 2026
- FDA UDI 1031933c-fc6c-4cf4-aca0-4a35ee4d73e8 36 fields · synced May 30, 2026
- EUDAMED 6047b0c4-ae91-4559-ae3d-e9f64bf56544 61 fields · synced Jul 9, 2026
- EUDAMED 580ce5a9-5fcb-4f65-a6e5-f4a7965470e6 61 fields · synced Jul 9, 2026
- EUDAMED 7662d474-a666-46d3-b4c8-45149e1d8fcb 61 fields · synced Jul 12, 2026
- EUDAMED 89a80386-dc62-439a-abb2-e04a28f3e48a 61 fields · synced Jul 22, 2026
- EUDAMED f0584568-975a-4d7d-98c2-53c9cbb06066 61 fields · synced Jul 30, 2026