NIPRO TP-SURE

GUDID 10383790004500

TRANSDUCER PROTECTOR

NIPRO MEDICAL CORPORATION

Haemodialysis system transducer protector Haemodialysis system transducer protector

• Primary Device ID: 10383790004500
• NIH Device Record Key: 094b5856-2082-4713-ab86-53418e77cdc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIPRO TP-SURE
• Version Model Number: TPSURE+1
• Company DUNS: 797372554
• Company Name: NIPRO MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383790004503 [Primary]
GS1	10383790004500 [Package]; Contains: 00383790004503; Package: Carton [100 Units]; In Commercial Distribution
GS1	40383790004501 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• FIB: PROTECTOR, TRANSDUCER, DIALYSIS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-16

Devices Manufactured by NIPRO MEDICAL CORPORATION

• 10383790000304 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (14Gx1") 12" tube, fixed hub
• 00383790000345 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (14Gx1") 12" tube, fixed hub (twin pack)
• 10383790000366 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1") 12" tube, fixed hub
• 10383790000373 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1") 12" tube, rotating hub
• 10383790000380 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1-1/4") 12" tube, fixed hub
• 10383790000397 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1-1/4") 12" tube, rotating hub
• 00383790000406 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (15Gx1") 12" tube, fixed hub (twin pack)
• 10383790000427 - Nipro SafeTouch TULIP Safety Fistula Needle: 2023-09-25 SafeTouch Tulip Safety AVF (16Gx1") 12" tube, fixed hub