← Back to catalogue

Sharn Inc

FDA UDI

Class I (US FDA UDI)

by Sharn Anesthesia

Identity

Trade Name
Sharn Inc FDA UDI
Generic Name
Ambulatory non-insulin infusion pump, mechanical, single-use FDA UDI
Device Name
DISPOS PRESS INFUSER BAG W/STOPCOCK,500 CC 6/PK FDA UDI
Model / Reference
PI-803S-6 FDA UDI
Description
DISPOS PRESS INFUSER BAG W/STOPCOCK,500 CC 6/PK FDA UDI

Identifiers

Catalog Number
PI-803S-6 FDA UDI
Primary DI / UDI-DI
00817518021546 FDA UDI
FDA Product Code
KZD FDA UDI
GMDN Term
Ambulatory non-insulin infusion pump, mechanical, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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: Ambulatory non-insulin infusion pump, mechanical, single-use

Sharn Inc by Sharn Anesthesia — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory non-insulin infusion pump, mechanical, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sharn Anesthesia

Sources (1)

  • FDA UDI 7f468ac7-0295-4a24-9957-b837c4737893 35 fields · synced May 30, 2026