DEVICE: Prontosan® (04046964295782)
Device Identifier (DI) Information
Prontosan®
400441
In Commercial Distribution
400441
B. BRAUN MEDICAL INC.
400441
In Commercial Distribution
400441
B. BRAUN MEDICAL INC.
Prontosan® Wound Irrigation Solution, 350 mL Bottle
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
59523 | Antimicrobial wound irrigation solution |
A solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FRO | Dressing, wound, drug |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: AVOID EXCESSIVE HEAT |
Special Storage Condition, Specify: DO NOT REFRIGERATE |
Special Storage Condition, Specify: Store at room temp |
Special Storage Condition, Specify: Do not freeze |
Special Storage Condition, Specify: |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Volume : 350.000 ML |
Device Record Status
5531c841-1ed5-45c2-9e3b-bf99ad2e2476
September 08, 2023
9
September 23, 2016
September 08, 2023
9
September 23, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046964295775
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
BBMUS_Service.EmailOrders@bbraun.com