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 ID10814321020466
NIH Device Record Keyac7a603d-47d4-4f19-b42b-3c075c122248
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffloShield
Version Model Number8600
Catalog Number8600
Company DUNS788403103
Company NameINTERNATIONAL BIOPHYSICS CORPORATION
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814321020469 [Unit of Use]
GS110814321020466 [Primary]

FDA Product Code

OEANon-Surgical Isolation Gown

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-20
Device Publish Date2019-12-12

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, 2.8mm2021-12-14 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, 3.6mm2021-12-14 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, 4.0mm2021-12-14 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, 4.4mm2021-12-14 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, 4.8mm2021-12-14 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, 5.2mm2021-12-14 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

Trademark Results [AffloShield]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFLOSHIELD
AFFLOSHIELD
87680453 not registered Live/Pending
International Biophysics Corporation
2017-11-10

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