← Back to catalogue
Freevent Neckband, two-piece, large
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 1662
Identity
- Trade Name
- Freevent Neckband, two-piece, large EUDAMEDFDA UDI
- Generic Name
- Tracheostomy tube neck holder, single-use FDA UDI
- Device Name
- Freevent Neckband EUDAMEDFreevent Neckband is used for holding a tube or button that connects to the trachea in place. It is a single use device intended for adult and pediatric patients. Not for neonatal use. FDA UDIThe Freevent Neckbands are used for holding a tube/button in place by wearing it around the neck and connecting the ends of the neckband to the tube/button. FDA UDI
- Model / Reference
- 1662 EUDAMEDFDA UDI1762 FDA UDI
- Description
- Freevent Neckband is used for holding a tube or button that connects to the trachea in place. It is a single use device intended for adult and pediatric patients. Not for neonatal use. FDA UDIThe Freevent Neckbands are used for holding a tube/button in place by wearing it around the neck and connecting the ends of the neckband to the tube/button. FDA UDI
Identifiers
- Catalog Number
- 1762 FDA UDI1662 FDA UDI
- Primary DI / UDI-DI
- 07331791012945 EUDAMEDFDA UDI07331791013638 FDA UDI
- Basic UDI-DI
- 7331791-GEN-A-000-0005-EM EUDAMED
- Unit of Use DI
- 07331791016646 EUDAMED
- FDA Product Code
- CBH FDA UDI
- EMDN Code
- R01058099 TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES EUDAMED
- GMDN Term
- Tracheostomy tube neck holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5770 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 25 Centimeter FDA UDILength — 55 Centimeter FDA UDI
Freevent Neckband, two-piece, large by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (3)
- FDA UDI 48b7dca5-488e-4f6e-87f2-f85af5d4fb09 38 fields · synced Jul 26, 2026
- FDA UDI 24b1c515-5553-4aed-99ff-4c700a2b85bb 37 fields · synced May 30, 2026
- EUDAMED 9f4d081c-9adc-4be2-a090-b1f84972146d 61 fields · synced Jul 26, 2026