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Diversatek Healthcare

FDA UDI

Class I (US FDA UDI)

by Diversatek Healthcare

Identity

Trade Name
Diversatek Healthcare FDA UDI
Generic Name
Surgical irrigation tubing set, single-use FDA UDI
Device Name
Infiltration Tubing for Peristaltic Pumps FDA UDI
Model / Reference
SU1168 FDA UDI
Description
Infiltration Tubing for Peristaltic Pumps FDA UDI

Identifiers

Catalog Number
SU1168 FDA UDI
Primary DI / UDI-DI
M783SU11680 FDA UDI
FDA Product Code
GBX FDA UDI
GMDN Term
Surgical irrigation tubing set, single-use 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

Category: Surgical irrigation tubing set, single-use

Diversatek Healthcare by Diversatek Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation tubing set, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 69e16e2d-9f81-4b31-ad6e-9b007647d46b 35 fields · synced May 30, 2026