DEVICE: HCS (00849027001405)
Device Identifier (DI) Information
HCS
HCS3003
In Commercial Distribution
DYAD MEDICAL SOURCING, LLC
HCS3003
In Commercial Distribution
DYAD MEDICAL SOURCING, LLC
Isolation Gown, SMS AAMI Level 1, Yellow, Large, Elastic Cuff, Tie Waist, Neck Tab Closure, Latex Free
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
35492 | Isolation gown, single-use |
A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OEA | Non-Surgical Isolation Gown |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4a28b5fe-2ae9-48f5-bdc7-703ff1584b64
January 08, 2020
1
December 31, 2019
January 08, 2020
1
December 31, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10849027001402 | 5 | 00849027001405 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
20849027001409
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined