FDA.reportPublic FDA data

NA

Primary DI
00085412025360
Brand
NA
Company
BAXTER HEALTHCARE CORPORATION
Model
5C4527
Catalog number
5C4527
Device description
The Short Nose Clamp for Outlet Port of Plastic Container is designed to facilitate peritoneal dialysis set connector insertion into and removal from, Peritoneal Dialysis Solution in plastic container.
Published
2019-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKKCLAMP, LINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKKClamp, LineGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412025365PackageGS112In Commercial Distribution
00085412025360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541202536550085412025365
00085412025360000854120253600854120253600085412025360

GMDN Terms#

Term, Definition table
TermDefinition
Medical tubing clip/clamp, temporary, non-calibrated, reusableA non-sterile, manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303MEDINFO_MEDPRODUCTS@BAXTER.COM

Regulatory Flags#

DUNS number
005083209
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24
00085412017716INTERLINK/CONTINU-FLO3C00623C00622016-09-24
00085412046389CLEARLINK/DUO-VENT2C88752C88752016-09-24
00085412048499CLEARLINK/DUO-VENT2H84802H84802016-09-24
00085412048932CLEARLINK2C84012C84012016-09-24
00085412048949CLEARLINK2C84022C84022016-09-24
00085412048987CLEARLINK/CONTINU-FLO2C85462C85462016-09-24
00085412048994CLEARLINK/CONTINU-FLO2C85192C85192016-09-24
00085412049090CLEARLINK2H84012H84012016-09-24
00085412051703CLEARLINK/CONTINU-FLO2C85152C85152016-09-24
00085412068190INTERLINK2H64012H64012016-09-24
00085412069302CLEARLINK/CONTINU-FLO/CONTROL-A-FLO2C88952C88952016-09-24
00085412071107CLEARLINK/CONTINU-FLO/DUO-VENT2C85412C85412016-09-24
00085412071190CLEARLINK2C84252C84252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414208233ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2025-02-10
57332414208238ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2025-02-10
13700911900928Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
13700911900935Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
13700911900942Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
23700911900925Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
23700911900932Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
23700911900949Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
13700911900621Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
13700911900638Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
13700911900645Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
23700911900628Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
23700911900635Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
23700911900642Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
36641670011528rescuCLAMP™ Catheter Repair ClampCardiomed Supplies IncFKK2021-04-21
16641670011517rescuCLAMP™ Catheter Repair ClampCardiomed Supplies IncFKK2021-04-21
00852250006093Lifemed Line ClampLIFEMED OF CALIFORNIAFKK2019-03-20
00852250006109Lifemed Coated Line ClampLIFEMED OF CALIFORNIAFKK2019-03-20
00085412070643ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2019-03-15
50085412025365NABAXTER HEALTHCARE CORPORATIONFKK2019-03-15
50085412070648ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2019-03-15