Pos-T-Vac A121

GUDID 00656535000420

POS-T-VAC INC

Penile vacuum device

• Primary Device ID: 00656535000420
• NIH Device Record Key: ba76e60d-5fe6-42e4-8547-923e670997ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pos-T-Vac
• Version Model Number: Ultimate II Round Ring X
• Catalog Number: A121
• Company DUNS: 186548160
• Company Name: POS-T-VAC INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00656535000420 [Primary]

FDA Product Code

• LKY: Device, External Penile Rigidity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-28
• Device Publish Date: 2018-08-28

On-Brand Devices [Pos-T-Vac]

• 00656535000949: Ring Loader
• 00656535000925: VT-1 Pump Head
• 00656535000918: PTV Manual 3000/MOS System
• 00656535000895: MVP-700 Basic System
• 00656535000888: MVP-700 Pump Head
• 00656535000871: MVP-700 Complete System
• 00656535000864: Large MVP Tube
• 00656535000857: Large Tube
• 00656535000840: Large Slip Tube
• 00656535000833: Scrotal Shield 1"
• 00656535000826: Scrotal Shield 3/4"
• 00656535000819: PTV Automatic 2000/BOS-2000-2 Slip
• 00656535000802: BOS-2000-2 Slip Pump Head
• 00656535000796: BOS-2000-3 Twist Basic System
• 00656535000789: BOS-2000-3 Twist System
• 00656535000772: PTV Automatic 3000/BOS-2000-3 (Slip)
• 00656535000765: AVP-1000/BOS-2000-3 (Slip)
• 00656535000758: BOS-2000-3 Complete System
• 00656535000741: BOS-2000-3 Pump Head (Slip)
• 00656535000734: IVP-600 System
• 00656535000727: BOS-2000-3 International With RL
• 00656535000703: IVP-600 Pump Head
• 00656535000673: BOS-2000-3 Twist Pump Head
• 00656535000666: BOS-2000-2 Pump Head
• 00656535000659: Mach 1 Ring 8
• 00656535000642: Mach 1 Ring 7
• 00656535000635: Mach 1 Ring 6
• 00656535000628: Mach 1 Ring 5
• 00656535000598: Ultimate II Round Ring 4
• 00656535000581: Ultimate II Round Ring 3
• 00656535000574: Ultimate II Round Ring 2
• 00656535000567: Ultimate II Round Ring 1
• 00656535000536: Cone White
• 00656535000529: Cone Grey
• 00656535000512: Bushing Small
• 00656535000505: Bushing Slip
• 00656535000499: Tube Slip
• 00656535000482: Twist Lock Tube
• 00656535000451: Bushing C
• 00656535000444: Bushing B
• 00656535000437: Bushing A
• 00656535000420: Ultimate II Round Ring X
• 00656535000390: BOS-2000-2 Complete System
• 00656535000284: Sustain