Shape II System Refurbished

FDA UDI

Class II (US FDA UDI)

by Shape Medical Systems, Inc.

Identity

Trade Name: Shape II System Refurbished FDA UDI
Generic Name: Pulmonary function analysis system, adult FDA UDI
Device Name: Full Shape II system with paramagnetic analyzer FDA UDI
Model / Reference: 0012-9012 FDA UDI
Description: Full Shape II system with paramagnetic analyzer FDA UDI

Identifiers

Primary DI / UDI-DI: B2009012 FDA UDI
510(k) Number: K150888 FDA UDI
FDA Product Code: BTY FDA UDI
GMDN Term: Pulmonary function analysis system, adult FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulmonary function analysis system, adult

Shape II System Refurbished by Shape Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K150888 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: Shape Medical Systems, Inc.

Sources (1)

FDA UDI e1a684a9-2db6-4409-82b7-4b7422e13c21 34 fields · synced May 30, 2026