Identity
- Trade Name
- Andersen Nasogastric Tube, 16 Fr. FDA UDI
- Generic Name
- Nasogastric/orogastric tube FDA UDI
- Device Name
- Andersen Nasogastric Tube, 16 Fr. (Individual) FDA UDI
- Model / Reference
- AN10.00 FDA UDI
- Description
- Andersen Nasogastric Tube, 16 Fr. (Individual) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060171440291 FDA UDI
- 510(k) Number
- K935688 FDA UDI
- FDA Product Code
- BSS FDA UDI
- GMDN Term
- Nasogastric/orogastric tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nasogastric/orogastric tube
Andersen Nasogastric Tube, 16 Fr. by Andersen Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K935688 also covers:
- AN10 - Andersen Nasogastric Tube, 16 Fr. (Box 10 Ct.) — ANDERSEN PRODUCTS, INC.
- AN10 - Andersen Nasogastric Tube, 16 Fr. (Case 50 Ct.) — ANDERSEN PRODUCTS, INC.
- AN10 - Andersen Nasogastric Tube, 16 Fr. (Overpack 250 Ct.) — ANDERSEN PRODUCTS, INC.
- AN10.05 - 16 Fr. Nasogastric Tube (5-lang) (Box 10 Ct.) — ANDERSEN PRODUCTS, INC.
- AN10.05 - 16 Fr. Nasogastric Tube (5-lang) (Case 50 Ct.) — ANDERSEN PRODUCTS, INC.
- AN10.05 - 16 Fr. Nasogastric Tube (5-lang) (Individual) — ANDERSEN PRODUCTS, INC.
- AN10.05 - 16 Fr. Nasogastric Tube (5-lang) (Overpack 250 Ct.) — ANDERSEN PRODUCTS, INC.
- AN10.15 - 16 Fr. Nasogastric Tube w/stylet (5-lang) (Box 10 Ct.) — ANDERSEN PRODUCTS, INC.
- AN10.15 - 16 Fr. Nasogastric Tube w/stylet (5-lang) (Case 50 Ct.) — ANDERSEN PRODUCTS, INC.
- AN10.15 - 16 Fr. Nasogastric Tube w/stylet (5-lang) (Overpack 250 Ct.) — ANDERSEN PRODUCTS, INC.
- AN10S (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet — ANDERSEN PRODUCTS, INC.
- AN10S - (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet (Box 10 Ct.) — ANDERSEN PRODUCTS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Andersen Products, Inc.
Sources (1)
- FDA UDI f96b8997-8541-4613-b33e-775d3383240e 34 fields · synced May 31, 2026