Identity
- Trade Name
- Convenience Bag EUDAMEDFDA UDI
- Generic Name
- Emesis bag FDA UDI
- Device Name
- Vomit Bag EUDAMEDConvenience Bag without Hand Protection, EU (White) FDA UDI
- Model / Reference
- 7000E EUDAMEDFDA UDI
- Description
- Convenience Bag without Hand Protection, EU (White) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810050854235 EUDAMED00810050854238 FDA UDI
- Basic UDI-DI
- 081005085EMEBAGTD EUDAMED
- Unit of Use DI
- 00810050854238 EUDAMED
- FDA Product Code
- FNY FDA UDI
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
- GMDN Term
- Emesis bag FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6730 FDA UDI
- Market of Registration
- Iceland 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Negative-pressure wound therapy system canister
Convenience Bag by Typenex Medical, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081005085EMEBAGTD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Typenex Medical, LLC
- EUDAMED SRN
- US-MF-000024001
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED a5160c06-3216-4e40-ac46-b7cc66be0851 61 fields · synced Jul 9, 2026
- FDA UDI b3881045-2021-42f4-baa8-2cdf19e208d8 33 fields · synced May 29, 2026