Vacuum Bag

GUDID 00815212021299

Izi Medical Products, LLC

Vacuum-mould patient positioning system

• Primary Device ID: 00815212021299
• NIH Device Record Key: 4f452c67-bcad-4cc2-a705-edb2383ac0be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vacuum Bag
• Version Model Number: VB707020
• Company DUNS: 933506164
• Company Name: Izi Medical Products, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815212021299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132124

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-13

On-Brand Devices [Vacuum Bag]

• 00815212023002: VB1508055
• 00815212021329: VB1045320NV
• 00815212021312: VB1007030NV
• 00815212021305: VB707020B
• 00815212021299: VB707020
• 00815212021282: VB507015B
• 00815212021275: VB507015
• 00815212021268: VB2550225B
• 00815212021251: VB2550225
• 00815212021244: VB20251B
• 00815212021237: VB20251
• 00815212021220: VB200100120B
• 00815212021213: VB200100120
• 00815212021206: VB1507560B
• 00815212021190: VB1507560
• 00815212021183: VB15010075B
• 00815212021176: VB15010075
• 00815212021169: VB1045320
• 00815212021152: VB1007040B
• 00815212021145: VB1007040
• 00815212021138: VB1007035B
• 00815212021121: VB1007035
• 00815212021114: VB1007030B
• 00815212021107: VB1007030
• 00815212021091: VB1006021
• 00815212021084: VB10010040B
• 00815212021077: VB10010040