FDA.reportPublic FDA data

ULTRACLAMP

Primary DI
07332414208233
Brand
ULTRACLAMP
Company
BAXTER HEALTHCARE CORPORATION
Model
5C4957
Catalog number
5C4957
Device description
UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag Container or any Vantive Y-Set. The clamp is specifically designed to assist individuals who experience difficulty in operating other ancillary clamps or pre-attached clamps.
Published
2025-02-10
Public version status
New
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
57332414208238PackageGS112In Commercial Distribution
00085412070643PreviousGS10
07332414208233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5733241420823857332414208238
00085412070643000854120706430854120706430085412070643
07332414208233073324142082337332414208233

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Store the clamp in open position to retain original configuration

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
Expiration date on label
true
No natural rubber latex
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
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
00085412025360NABAXTER HEALTHCARE CORPORATIONFKK2019-03-15
00085412070643ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2019-03-15
50085412025365NABAXTER HEALTHCARE CORPORATIONFKK2019-03-15
50085412070648ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2019-03-15