FDA.report

AESCULAP

Primary DI
04046964930751
Brand
AESCULAP
Company
AESCULAP, INC.
Model
US754
Catalog number
US754
Device description
INTERNAL PROCESS INDICATORS
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
JOJIndicator, physical/chemical sterilization process
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications

CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964930751PrimaryGS10
04046964930744Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964930751040469649307514046964930751
04046964930744040469649307444046964930744

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, Specify00CONTROLLED ROOM TEMPRATURE
Special Storage Condition, Specify00Store at controlled room temp

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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04046955741366AESCULAPFK917NBFK917NB2025-08-17
04046955741373AESCULAPFK961NBFK961NB2025-08-17
04046955741380AESCULAPFK962NBFK962NB2025-08-17

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