FDA.reportPublic FDA data

Prontosan®

Primary DI
04046964295744
Brand
Prontosan®
Company
B. BRAUN MEDICAL INC.
Model
400440
Catalog number
400440
Device description
Prontosan® Wound Irrigation Solut ion, 40 mL Ampule
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964295744PackageGS15In Commercial Distribution
04046964295768PackageGS14In Commercial Distribution
04046964295751PrimaryGS10
04046964295737Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964295744040469642957444046964295744
04046964295768040469642957684046964295768
04046964295751040469642957514046964295751
04046964295737040469642957374046964295737

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solution, sterileA sterile solution that includes an antimicrobial agent [e.g., polyhexanide (PHMB)] intended to be used to irrigate, clean/moisten, and decontaminate a wound or burn to aid in autolytic debridement, and to moisten/lubricate a wound dressing. It may be used for acute or chronic wounds, including first or second degree burns. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00AVOID EXCESSIVE HEAT
Special Storage Condition, Specify00Do not freeze
Special Storage Condition, Specify00DO NOT REFRIGERATE
Special Storage Condition, Specify00DO NOT REFRIGERATE OR FREEZE.
Special Storage Condition, Specify00Store at room temp
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964315954Design Options®5554845554842016-09-23
04046964989742Design Options®5521175521172016-10-24
04046955582969Perfusor®8713330-998713330-992026-06-07
04046955862634Design Options®5522035522032026-06-01
04046955966264Design Options®5522075522072026-06-01
04046964177347Perifix®3320873320872016-09-23
04046964178900Perifix®3322643322642016-09-23
04046955672370Design Options®5606805606802026-05-24
04046955900268Design Options®5517695517692026-05-14
04046964308024Design Options®5517695517692016-09-23
04045928020392Design Options®5521235521232026-05-11
04045928020699Design Options®5521795521792026-05-11
04046955803125Clik-Fix®LLS-1021BLLS-1021B2023-01-06
04046955803163Clik-Fix®LLS-1024BLLS-1024B2023-01-06
04046955803194Clik-Fix®NPS-1006BNPS-1006B2022-12-22
04046955803231Clik-Fix®LLSK-1024BLLSK-1024B2023-01-06
04046955803255Clik-Fix®PCS-1011BPCS-1011B2022-12-22
04046955803286Clik-Fix®WCS-1000BWCS-1000B2023-03-13
04046955803316Clik-Fix®WCS-1003BWCS-1003B2023-03-06
04046955803347Clik-Fix®WCS-1006BWCS-1006B2023-01-06

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10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
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