Identity
- Trade Name
- X-Changer 19 Fr; Length: 80 cm; O2-15 mm O.D.; O2 EUDAMEDX-Changer FDA UDI
- Generic Name
- Endotracheal tube introducer, single-use FDA UDI
- Device Name
- Intubation Aids - X-Changer EUDAMED19 Fr; Length: 80 cm; O2-15 mm O.D.; O2 FDA UDI
- Model / Reference
- 33-40-800-1 EUDAMEDFDA UDI
- Description
- 19 Fr; Length: 80 cm; O2-15 mm O.D.; O2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250105629705 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-1.6.5-V01-MT EUDAMED
- FDA Product Code
- BSR FDA UDI
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Endotracheal tube introducer, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5790 FDA UDI
- Market of Registration
- Germany 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
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 — 80 Centimeter FDA UDIOuter Diameter — 15 Millimeter FDA UDI
Category: Endotracheal tube introducer, single-use
X-Changer by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endotracheal tube introducer, single-use.
- Bougie / Introducer OD 5.0mm (15Ch) 700mm — FLEXICARE MEDICAL LIMITED · Class I
- Frova — COOK INCORPORATED · Class I
- Runnels Steerable Introducer™ #2 Oral/Nasal — THROUGH THE CORDS, LLC · Class I
- Frova — COOK INCORPORATED · Class II
- Truer Bougie — TRUER MEDICAL, INC. · Class I
- Runnels Steerable Introducer™ #4 Oral — THROUGH THE CORDS, LLC · Class I
- Intuitive Depth Bougie™ (IDB), Coude Tip — THROUGH THE CORDS, LLC · Class I
- COOK — William Cook Europe ApS · Class II
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
- VBM Medizintechnik GmbH
Sources (2)
- FDA UDI 8a6ad8e8-b8f4-421f-9872-7674a5efce47 36 fields · synced Jun 18, 2026
- EUDAMED 1d6b3692-da1b-4a49-bc6d-5d5aa91b1fac 61 fields · synced Jun 18, 2026