FDA.reportPublic FDA data

AN2203.04 - Biological Indicators for EtO (50 Unit Box)

Primary DI
05060171440802
Brand
AN2203.04 - Biological Indicators for EtO (50 Unit Box)
Company
ANDERSEN PRODUCTS, INC.
Model
AN2203.04
Device description
AN2203.04 - Biological Indicators for EtO (50 Unit Box)
Published
2017-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRCIndicator, Biological Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060171440802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060171440802050601714408025060171440802

GMDN Terms#

Term, Definition table
TermDefinition
Biological sterilization indicatorA sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041867342
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060171440291Andersen Nasogastric Tube, 16 Fr. AN10.002017-01-24
05060171440307AN10S (10.11) - Andersen Nasogastric Tube, 16 Fr., with StyletAN10.11 2017-01-24
05060171440314AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr.AN11.002017-01-24
05060171440321AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (IndAN11.112017-01-24
05060171440338AN11.50 - Andersen Nasogastric Tube, Pediatric, 10 Fr., Short (Individual)AN11.502017-01-24
05060171440345AN20 - Andersen Long Non-Mercury Weighted Sump Tube, 16 Fr. (Individual)AN20.002017-01-24
05060171440352AN22 - Andersen Miller-Abbott Type Intestinal Tube, 16 Fr., Pre-Weighted (IndiviAN22.002017-01-24
05060171440383AN10 - Andersen Nasogastric Tube, 16 Fr. (Box 10 Ct.)AN10.002017-01-24
05060171440390AN10 - Andersen Nasogastric Tube, 16 Fr. (Case 50 Ct.)AN10.002017-01-24
05060171440406AN10 - Andersen Nasogastric Tube, 16 Fr. (Overpack 250 Ct.)AN10.002017-01-24
05060171440413AN10S - (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet (Box 10 Ct.)AN10.112017-01-24
05060171440420AN10S - (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet (Case 50 Ct.)AN10.11 2017-01-24
05060171440437AN10S - (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet (Overpack 250 CAN10.11 2017-01-24
05060171440444AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Box 10 Ct.)AN11.002017-01-24
05060171440451AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Case 50 Ct.)AN11.002017-01-24
05060171440468AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Overpack 250 Ct.)AN11.002017-01-24
05060171440475AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (BoxAN11.112017-01-25
05060171440482AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (CasAN11.112017-01-25
05060171440499AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (OveAN11.112017-01-25
05060171440505AN11.50 - Andersen Nasogastric Tube, Pediatric, 10 Fr., Short (Box 10 Ct.)AN11.502017-01-25

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