Vacuum Bag

FDA UDI

Class II (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: Vacuum Bag FDA UDI
Generic Name: Vacuum-mould patient positioning system FDA UDI
Model / Reference: VB707020B FDA UDI

Identifiers

Primary DI / UDI-DI: 00815212021305 FDA UDI
510(k) Number: K132124 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Vacuum-mould patient positioning system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vacuum-mould patient positioning system

Vacuum Bag by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Izi Medical Products Llc

Sources (1)

FDA UDI df9398d5-3ed0-4dd2-81da-7452d2f1bd53 33 fields · synced Jun 8, 2026