Identity
- Trade Name
- Dale Nasogastric Tube Holder EUDAMEDDale Nasogastric Tube Holder, One Leg FDA UDI
- Generic Name
- Nasogastric tube holder, noninvasive FDA UDI
- Device Name
- Dale Nasogastric Tube Hold EUDAMEDDale Nasogastric Tube Holder, Ultragrip, One Leg FDA UDI
- Model / Reference
- 163 EUDAMEDFDA UDI
- Description
- Dale Nasogastric Tube Holder, Ultragrip, One Leg FDA UDI
Identifiers
- Catalog Number
- 163 FDA UDI
- Primary DI / UDI-DI
- 00817612020971 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817612021636A EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- G0180 ORO-OESOPHAGEAL TUBES - ACCESSORIES EUDAMED
- GMDN Term
- Nasogastric tube holder, noninvasive FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 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
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
No
FDA UDI
Dale Nasogastric Tube Holder by Dale Medical Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0817612021636A | Class I | Active |
| 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
- Dale Medical Products, Inc.
- EUDAMED SRN
- US-MF-000019061
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 599a36db-fbf7-4337-bc03-63d8bfddfdfc 61 fields · synced Jun 9, 2026
- FDA UDI aa7159d6-9a76-44be-9097-d2c7c7d9ac79 35 fields · synced May 24, 2026