Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal

GUDID 00810180842457

Dynarex Corporation

Patient gown, single-use
Primary Device ID00810180842457
NIH Device Record Key56d8662d-26e3-46ae-a0cc-56324bdf3de9
Commercial Distribution StatusIn Commercial Distribution
Brand NameExam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal
Version Model Number8114
Company DUNS008124539
Company NameDynarex Corporation
Device Count100
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 Datetrue
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
GS100616784811437 [Primary]
GS100810180842457 [Unit of Use]

FDA Product Code

FMEGown, Examination

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-13
Device Publish Date2026-01-05

Devices Manufactured by Dynarex Corporation

00810180842440 - Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Universal2026-01-13
00810180842457 - Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal2026-01-13
00810180842457 - Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal2026-01-13
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00840117344174 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 12 FR (4.0 mm),30.5 cm/12 in2026-01-13 Double Swivel Elbow (DSE), Tracheal, Adult/Pediatric CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1.
00840117344181 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 in2026-01-13 Double Swivel Elbow (DSE), Tracheal, Adult CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1. 15 mm x 22

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