DEVICE: SafeWash Saline (00714196245076)
Device Identifier (DI) Information
SafeWash Saline
00245
In Commercial Distribution
DERMARITE INDUSTRIES LLC
00245
In Commercial Distribution
DERMARITE INDUSTRIES LLC
SafeWash™ Saline is a sterile first-aid, multi-use jet lavage for wound dressing irrigation and wound cleansing. SafeWash™ Saline wound wash is intended for: moistening and lubricating absorbent wound dressings; cleansing wounds, scrapes and minor burns; flushing and cleansing wounds of exudate, loose necrotic tissue, and foreign material such as dirt and debris. Contains 0.9% Sodium Chloride Solution.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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37298 | Wound irrigation sterile saline |
A sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FQH | Lavage, Jet |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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
972fd3bf-a11c-486e-9c55-5601dd4c2e0e
March 29, 2018
2
September 20, 2016
March 29, 2018
2
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10714196245073 | 12 | 00714196245076 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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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