AN2203.04 - Biological Indicators for EtO (50 Unit

GUDID 05060171440802

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

ANDERSEN PRODUCTS, INC.

Biological sterilization indicator
Primary Device ID05060171440802
NIH Device Record Keyc3a88a3b-77b1-4628-a2f6-7760b67bda2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAN2203.04 - Biological Indicators for EtO (50 Unit
Version Model NumberAN2203.04
Company DUNS041867342
Company NameANDERSEN PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060171440802 [Primary]

FDA Product Code

FRCIndicator, Biological Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-01-25

Devices Manufactured by ANDERSEN PRODUCTS, INC.

05060171440291 - Andersen Nasogastric Tube, 16 Fr. 2018-07-06 Andersen Nasogastric Tube, 16 Fr. (Individual)
05060171440307 - AN10S (10.11) - Andersen Nasogastric Tube, 16 Fr.,2018-07-06 AN10S (10.11) - Andersen Nasogastric Tube, 16 Fr., with Stylet (Individual)
05060171440314 - AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr2018-07-06 AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Individual)
05060171440321 - AN11S - (11.11) - Andersen Nasogastric Tube, Pedia2018-07-06 AN11S - (11.11) - Andersen Nasogastric Tube, Pediatric, 10 Fr., with Stylet (Individual)
05060171440338 - AN11.50 - Andersen Nasogastric Tube, Pediatric, 102018-07-06 AN11.50 - Andersen Nasogastric Tube, Pediatric, 10 Fr., Short (Individual)
05060171440345 - AN20 - Andersen Long Non-Mercury Weighted Sump Tub2018-07-06 AN20 - Andersen Long Non-Mercury Weighted Sump Tube, 16 Fr. (Individual)
05060171440352 - AN22 - Andersen Miller-Abbott Type Intestinal Tube2018-07-06 AN22 - Andersen Miller-Abbott Type Intestinal Tube, 16 Fr., Pre-Weighted (Individual)
05060171440383 - AN10 - Andersen Nasogastric Tube, 16 Fr. (Box 10 C2018-07-06 AN10 - Andersen Nasogastric Tube, 16 Fr. (Box 10 Ct.)

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