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Standard Starter Set

FDA UDI

Class II (US FDA UDI)

by Sentec, Inc.

Identity

Trade Name
Standard Starter Set FDA UDI
Generic Name
Pulse Co-oximeter probe, reusable FDA UDI
Device Name
Standard Starter Set contains: Ear Clips (EC-MI) Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF) Membrane Changer tool (reloadable) (MC-R) Contact Gel (GEL-04) Service Gas (GAS-0812) FDA UDI
Model / Reference
SSET FDA UDI
Description
Standard Starter Set contains: Ear Clips (EC-MI) Multi-Site Attachment Rings for mature/intact skin (MAR-MI) Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF) Membrane Changer tool (reloadable) (MC-R) Contact Gel (GEL-04) Service Gas (GAS-0812) FDA UDI

Identifiers

Primary DI / UDI-DI
07640121880094 FDA UDI
FDA Product Code
LPP FDA UDI
KLK FDA UDI
DQA FDA UDI
DPZ FDA UDI
LKD FDA UDI
GMDN Term
Pulse Co-oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2500 FDA UDI
870.2700 FDA UDI
870.2710 FDA UDI
868.2480 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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

Standard Starter Set by Sentec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sentec, Inc.

Sources (1)

  • FDA UDI 3b5fda2e-fc20-4144-afe8-785578a81d32 35 fields · synced Jun 1, 2026