Identity
- Trade Name
- Ambu® Connecting Tube for Cuff Pressure Gauge Length: 100 cm ; female Luer Lock, male Luer EUDAMEDAmbu A/S FDA UDI
- Generic Name
- Endotracheal tube cuff inflator FDA UDI
- Device Name
- Cuff Pressure Gauges - Acc. Cuff Pressure Gauges EUDAMEDAmbu Connecting Tube for Cuff Pressure Gauge FDA UDI
- Model / Reference
- 321000702 EUDAMEDFDA UDI
- Description
- Ambu Connecting Tube for Cuff Pressure Gauge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250105628081 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-1.1.5-V3 EUDAMED
- 510(k) Number
- K912723 FDA UDI
- FDA Product Code
- BSK FDA UDI
- EMDN Code
- R01038001 ENDOTRACHEAL TUBE CUFFS INFLATION SYSTEMS EUDAMED
- GMDN Term
- Endotracheal tube cuff inflator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In 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
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
Dimensions & Sizes
- Size
- Length — 100 Centimeter FDA UDI
Category: Endotracheal tube cuff inflator
Ambu A/S by VBM Medizintechnik GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endotracheal tube cuff inflator.
- Venner™ Tracheal Seal Monitor — VENNER MEDICAL (SINGAPORE) PTE. LTD. · Class II
- Cuffix — Biovo Technologies , Ltd. · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- AincA® — Anesthesia Associates, Inc. · Class II
- IntelliCuff — HAMILTON MEDICAL, INC. · Class II
- TRACOE technic — Tracoe medical GmbH · Class II
- AG Cuffill Kruuse - VET — HOSPITECH RESPIRATION LTD · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K912723 also covers:
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
- VBM Medizintechnik GmbH
Sources (2)
- FDA UDI 4543e744-1df2-4c0e-9357-63e50391721d 37 fields · synced Jul 12, 2026
- EUDAMED d562763f-c71e-41fc-8064-acc61f603399 61 fields · synced Jul 12, 2026