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Montgomery® Salivary Bypass Tube

FDA UDI

Class I (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name
Montgomery® Salivary Bypass Tube FDA UDI
Generic Name
Polymeric oesophageal stent, non-bioabsorbable FDA UDI
Device Name
Size: 20 mm; Type: Clear FDA UDI
Model / Reference
322200 FDA UDI
Description
Size: 20 mm; Type: Clear FDA UDI

Identifiers

Catalog Number
322200 FDA UDI
Primary DI / UDI-DI
14063107100427 FDA UDI
510(k) Number
K812305 FDA UDI
FDA Product Code
KCF FDA UDI
GMDN Term
Polymeric oesophageal stent, non-bioabsorbable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

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
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 191 Millimeter FDA UDI
Outer Diameter — 20 Millimeter FDA UDI

Category: Polymeric oesophageal stent, non-bioabsorbable

Montgomery® Salivary Bypass Tube by Boston Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric oesophageal stent, non-bioabsorbable.

Cleared under the same submission

K812305 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Medical Products, Inc.

Sources (1)

  • FDA UDI 2ba019c0-5d5c-4f99-9e2c-e62e089b5104 38 fields · synced Jun 9, 2026