FDA.report

AESCULAP

Primary DI
04046964909863
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MD335
Catalog number
MD335
Device description
VH2O2 PROCESS INDICATOR CARD (MINI)
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FRGWrap, sterilization

Product Code Classifications

CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964909863PrimaryGS10
04046964909856Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964909863040469649098634046964909863
04046964909856040469649098564046964909856

GMDN Terms

TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00ACIDS AND SOURCE OF LIGHT
Special Storage Condition, Specify00Away from alk.chem,acids,light
Special Storage Condition, Specify00AWAY FROM ALKALINE CHEMICAL,

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
082594540
Device count
250
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
false
Sterilization required before use
false

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