Pulset

FDA UDI

Class I (US FDA UDI)

by SunMed

Identity

Trade Name: Pulset FDA UDI
Generic Name: Arterial blood sampling kit FDA UDI
Device Name: 3cc Syringe 23g x 1" (.6 x 25mm) Safety Tip 50u Balanced Heparin FDA UDI
Model / Reference: 3313-91-S FDA UDI
Description: 3cc Syringe 23g x 1" (.6 x 25mm) Safety Tip 50u Balanced Heparin FDA UDI

Identifiers

Primary DI / UDI-DI: 10889483558300 FDA UDI
FDA Product Code: CBT FDA UDI
GMDN Term: Arterial blood sampling kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Arterial blood sampling kit

Pulset by SunMed — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: SunMed

Sources (1)

FDA UDI 64009016-ca54-4f71-adf8-9d578846395e 33 fields · synced Jun 1, 2026