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Ni-Flex

FDA UDI

Class I (US FDA UDI)

by H.s. Hospital Service Spa

Identity

Trade Name
NI-FLEX FDA UDI
Generic Name
Non-vascular catheter introduction set FDA UDI
Device Name
FILO GUIDA 0.035"X1500MM FDA UDI
Model / Reference
NI-FLEX FDA UDI
Description
FILO GUIDA 0.035"X1500MM FDA UDI

Identifiers

Catalog Number
NIPJ 35150-H FDA UDI
Primary DI / UDI-DI
08033003344965 FDA UDI
FDA Product Code
KGZ FDA UDI
GMDN Term
Non-vascular catheter introduction set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 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

Yes

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 Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 1500 Millimeter FDA UDI
Outer Diameter — 0.035 Inch FDA UDI

Category: Non-vascular catheter introduction set

Ni-Flex by H.s. Hospital Service Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-vascular catheter introduction set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
H.s. Hospital Service Spa

Sources (1)

  • FDA UDI 1c39f817-f14d-447a-8847-4b6111030221 36 fields · synced May 30, 2026