Performance

FDA UDI

Class II (US FDA UDI)

by Blush Novelties

Identity

Trade Name: PERFORMANCE FDA UDI
Generic Name: Penile vacuum device FDA UDI
Device Name: Part Number: BL-08091. A medical grade ball pump, a flexible silicone tube. Includes a soft TPE cylinder seal. FDA UDI
Model / Reference: 101 Starter Series Pump-Red FDA UDI
Description: Part Number: BL-08091. A medical grade ball pump, a flexible silicone tube. Includes a soft TPE cylinder seal. FDA UDI

Identifiers

Catalog Number: BL-08091 FDA UDI
Primary DI / UDI-DI: 00853858007208 FDA UDI
FDA Product Code: LKY FDA UDI
GMDN Term: Penile vacuum device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5020 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

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Penile vacuum device

Performance by Blush Novelties — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Blush Novelties

Sources (1)

FDA UDI 0351ef1b-9f2e-4c9a-b246-849988f60bb3 34 fields · synced May 31, 2026