Stryker Sustainability Solutions

FDA UDI

Class II (US FDA UDI)

by Stryker Sustainability Solutions

Identity

Trade Name: Stryker Sustainability Solutions FDA UDI
Generic Name: Pulse oximeter probe, reprocessed FDA UDI
Model / Reference: 4001 FDA UDI

Identifiers

Catalog Number: 4001 FDA UDI
Primary DI / UDI-DI: 07613327610574 FDA UDI
510(k) Number: K222019 FDA UDI
FDA Product Code: NLF FDA UDI
GMDN Term: Pulse oximeter probe, reprocessed FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Dimensions & Sizes

Size: Length — 2.43 Inch FDA UDI

Category: Pulse oximeter probe, reprocessed

Stryker Sustainability Solutions by Stryker Sustainability Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reprocessed.

Orantech — Orantech Inc. · Class II
Pulse Oximeter — Rashman Corp. · Class II
Nellcor Pulse Oximeter Probe — RENU MEDICAL, INC · Class II
Masimo Pulse Oximeter Probe — RENU MEDICAL, INC · Class II
Welch Allyn SPO2 Sensor — MEDSOURCE INTERNATIONAL LLC · Class II
Orantech — Orantech Inc. · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
MEDLINE RENEWAL — MEDLINE INDUSTRIES, INC. · Class II

Cleared under the same submission

K222019 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Stryker Sustainability Solutions

Sources (1)

FDA UDI fb7f5c4f-444c-48a9-8cf1-c1c3a57b9c64 36 fields · synced May 30, 2026