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Envi

FDA UDI

Class I (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name
ENVI FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
NVI SHEATH 6F X 20CM FDA UDI
Model / Reference
35-501 FDA UDI
Description
NVI SHEATH 6F X 20CM FDA UDI

Identifiers

Primary DI / UDI-DI
H965355010 FDA UDI
510(k) Number
K170775 FDA UDI
FDA Product Code
GBX FDA UDI
GAA FDA UDI
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 FDA UDI
878.4800 FDA UDI
870.1340 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

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
Catheter Gauge — 6 French FDA UDI
Lumen/Inner Diameter — 0.5 Millimeter FDA UDI
Length — 20 Centimeter FDA UDI

Category: Vascular catheter introduction set, nonimplantable

Envi by Navilyst Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Cleared under the same submission

K170775 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Navilyst Medical, Inc.

Sources (1)

  • FDA UDI 8595030e-59e1-4489-bab4-9eec912d216e 36 fields · synced May 30, 2026