FDA.reportPublic FDA data

Wallace

Primary DI
15019315056697
Brand
Wallace
Company
ICU MEDICAL, INC.
Model
PEB623
Published
2016-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQFCATHETER, ASSISTED REPRODUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQFCatheter, Assisted ReproductionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315056691PackageGS110In Commercial Distribution
55019315056695PackageGS1100In Commercial Distribution
15019315056697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931505669135019315056691
5501931505669555019315056695
1501931505669715019315056697

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction catheter setA collection of sterile devices used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)], a procedure that may be administered transvaginally or laparoscopically. It typically consists of a transfer catheter and an outer guide sheath, or an inner and outer catheter; a stylet may be included to aid passage through the cervix. Some sets may include a trial transfer catheter set to assess/ensure that embryo placement will be successful. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709203263BivonaFT26IN40NGE030N2026-09-04
10887709203270BivonaXT26IS70NSC031N2026-09-04
10887709203287BivonaFT26IN40NSF032N2026-09-04
10887709203294BivonaFT26IN50NSF034N2026-09-04
10887709203300BivonaFT26IN55NSF033N2026-09-04
10887709203324BivonaFT26IN30NSE036N2026-09-04
10887709201641BivonaZT26DN50NSZ214S2026-08-27
10887709202174BivonaST26HN80ZSZ137N2026-08-27
10887709202426BivonaFT26HN45NSF207N2026-08-27
10887709202433BivonaFU26HN40NGF213N2026-08-27
10887709202440BivonaFT26HN45NGA211N2026-08-27
10887709202464BivonaFT26HN30NGE215N2026-08-27
10887709202471BivonaFT26HN35NGE214N2026-08-27
10887709202259BivonaFU26HN35NGA187N2026-08-26
10887709202266BivonaFT26HN35NGE188N2026-08-26
10887709202273BivonaFU26HN40NGA186N2026-08-26
10887709202280BivonaFT26HN35NGF189N2026-08-26
10887709202297BivonaFU26HN40NGF190N2026-08-26
10887709202303BivonaFT26HN40NSE076N2026-08-26
10887709202310BivonaFU26HN25NGE191N2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580745043785ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745043907ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745044232ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745044249ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
04580745043778ET CatheterKITAZATO CORPORATIONMQF2024-09-09
04580745043891ET CatheterKITAZATO CORPORATIONMQF2024-09-09
04580745044263ET CatheterKITAZATO CORPORATIONMQF2024-09-09
04580745044287ET CatheterKITAZATO CORPORATIONMQF2024-09-09
M803TMI1297Clear Shapeable Intrauterine Insemination catheter MEDGYN PRODUCTS, INC.MQF2024-01-03
03700111400023FRYDMAN® CLASSIC 4.5LABORATOIRE CCDMQF2023-12-05
03700111400030FRYDMAN® CLASSIC 5.5LABORATOIRE CCDMQF2023-12-05
03700111400047FRYDMAN ® SOFT WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111400061T.D.T.®SETLABORATOIRE CCDMQF2023-12-05
03700111400085INVENTCATH ECOLABORATOIRE CCDMQF2023-12-05
03700111400092STYLET FOR FRYDMAN® ULTRASOFT & FRYDMAN® ULTRASOFT echoLABORATOIRE CCDMQF2023-12-05
03700111400108CLASSIC ULTRASOFT 18 CMLABORATOIRE CCDMQF2023-12-05
03700111400122ULTRASOFT FRYDMAN ® SET ECHO WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111400139MOCK CATHETERLABORATOIRE CCDMQF2023-12-05
03700111400146CLASSIC ULTRASOFT MOCK 18 CMLABORATOIRE CCDMQF2023-12-05
03700111400191ULTRASOFT FRYDMAN ® SET ECHOLABORATOIRE CCDMQF2023-12-05
03700111400214ULTRASOFT FRYDMAN ® SET MOCKLABORATOIRE CCDMQF2023-12-05
03700111400221ULTRASOFT FRYDMAN® SET MOCK ECHOLABORATOIRE CCDMQF2023-12-05
03700111400269FRYDMAN® ULTRASOFTLABORATOIRE CCDMQF2023-12-05
03700111400276FRYDMAN®ULTRASOFT ECHOLABORATOIRE CCDMQF2023-12-05
03700111400290CLASSIC ULTRASOFT 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400306CLASSIC ULTRASOFT MOCK 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400351ECHOGYN®EMBRYOVIEW M 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400368ECHOGYN® EMBRYOVIEW M MOCK 23 CMLABORATOIRE CCDMQF2023-12-05
03700111400375ECHOGYN ® EMBRYOVIEW M 18 CMLABORATOIRE CCDMQF2023-12-05
03700111400382ECHOGYN® EMBRYOVIEW M MOCK 18 CMLABORATOIRE CCDMQF2023-12-05