Curved Insemina Intra Uterine Insemination Catheter Open Tip

Primary DI
00819374021890
Brand
Curved Insemina Intra Uterine Insemination Catheter Open Tip
Company
ALLWIN MEDICAL DEVICES, INC.
Model
Curved Insemina Open Tip
Catalog number
I-IUI-C-O
Published
2020-09-18
Public version status
New
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
MFDCannula, Intrauterine Insemination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFDCannula, Intrauterine InseminationObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190522000Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)Allwin Medical Devices, Inc.2019-11-14MQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819374021897PackageGS125In Commercial Distribution
00819374021890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081937402189710819374021897
00819374021890008193740218908193740218900819374021890

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction transfer catheter/setA device or collection of devices that includes a flexible polymer tube intended to be 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)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device.

Regulatory Flags#

DUNS number
796354509
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812261016597ASPIASPI Aspiration NeedleASPI22/302024-01-09
00819374021746SURESTRIPSURESTRIP Vitrification StrawSUS-Y2024-01-10
00812261010069allSoftallSoft Ureteral Stent Open TipSOT5/242024-01-09
00812261010823allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 10cPOS3/102024-01-09
00812261010830allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 12cPOS3/122024-01-09
00812261010847allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 14cPOS3/142024-01-09
00812261010854allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 16cPOS3/162024-01-09
00812261010861allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 10cPOS4/102024-01-09
00812261010878allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 12cPOS4/122024-01-09
00812261010885allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 14cPOS4/142024-01-09
00812261010892allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 16cPOS4/162024-01-09
00812261010908allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 10cPOS3/10-G2024-01-09
00812261010915allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 12cPOS3/12-G2024-01-09
00812261010922allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 14cPOS3/14-G2024-01-09
00812261010939allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 16cPOS3-16-G2024-01-09
00812261010946allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 10cPOS4/10-G2024-01-09
00812261010953allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 12cPOS4/12-G2024-01-09
00812261010960allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 14cPOS4/14-G2024-01-09
00812261010977allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 16cPOS4/16-G2024-01-09
00812261011806allDrainallDrain Percutaneous Nephrostomy Catheter PigtailPCN-P142024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812261016603Insemina Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00812261016610Stumpy Intra Uterine Insemination CannulaALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00812261016818Curved Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00812261016825Flexi Intra Uterine Insemination CatheterALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00812261016863Trackable Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00819374021814Insemina Open Tip Intra Uterine Insemination Catheter ALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00819374022019Trackable Intra Uterine Insemination Catheter Open TipALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00819374022491Flexi Intra Uterine Insemination Catheter Open TipALLWIN MEDICAL DEVICES, INC.MFD2020-09-18
00888937021332Wallace Artificial Insemination CatheterCoopersurgical, Inc.MFD2019-09-26
30888937021333Wallace Artificial Insemination CatheterCoopersurgical, Inc.MFD2019-09-26
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