DEVICE: Curaplex (00812277033915)
Device Identifier (DI) Information
Curaplex
8600-01375
In Commercial Distribution
8600-01375
BOUND TREE MEDICAL, LLC
8600-01375
In Commercial Distribution
8600-01375
BOUND TREE MEDICAL, LLC
*Custom* LMPD PPE KIT XL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
57792 | Surgical/medical respirator, antimicrobial |
A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. It is designed to create an airtight seal against the user’s face and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.
|
Active | false |
58390 | Visitor hygiene coverall |
A garment intended to be worn by a visitor, or staff, in a healthcare facility as temporary clean clothing when with patients in non-sterile environments that may require a higher level of hygiene than a normal patient ward [e.g., intensive care unit (ICU), postoperative recovery ward]. Also known as a jump suit, it is a one-piece suit (overall) with sleeves, trouser legs, and fasteners intended to be worn over existing clothing to provide a barrier to help prevent cross-contamination of infectious agents between visitor and patients. This is a single-use garment.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LYU | ACCESSORY, SURGICAL APPAREL |
NZJ | Respirator, n95, for use by the general public in public health medical emergencies |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a4613ea7-2723-4d7b-89d4-e69b4bf1769f
September 13, 2023
6
December 15, 2018
September 13, 2023
6
December 15, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00810094573034 | 25 | 00812277033915 | In Commercial Distribution | CS |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined