AffloShield 8600

GUDID 10814321020466

The AffloShield is a disposable gown intended for use with the AffloVest product line.

INTERNATIONAL BIOPHYSICS CORPORATION

Isolation gown, single-use

• Primary Device ID: 10814321020466
• NIH Device Record Key: ac7a603d-47d4-4f19-b42b-3c075c122248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AffloShield
• Version Model Number: 8600
• Catalog Number: 8600
• Company DUNS: 788403103
• Company Name: INTERNATIONAL BIOPHYSICS CORPORATION
• Device Count: 10
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814321020469 [Unit of Use]
GS1	10814321020466 [Primary]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

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: 2019-12-20
• Device Publish Date: 2019-12-12

Devices Manufactured by INTERNATIONAL BIOPHYSICS CORPORATION

• 10814321020152 - FloProbe 1/4’’ x 1/4" (Non Sterile): 2021-12-15 The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjun
• 10814321020176 - FloProbe 3/8’’ x 3/8” (Non Sterile): 2021-12-15 The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjun
• 10814321020213 - IBC Aortic Punch, Long, 2.8mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020220 - IBC Aortic Punch, Long, 3.6mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020237 - IBC Aortic Punch, Long, 4.0mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020244 - IBC Aortic Punch, Long, 4.4mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020251 - IBC Aortic Punch, Long, 4.8mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to
• 10814321020268 - IBC Aortic Punch, Long, 5.2mm: 2021-12-14 The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to