TEMPO 451512H0

GUDID 10705032008433

CATH TEMPO 5F MAN 100CM

CORDIS CORPORATION

Angiographic catheter, single-use

• Primary Device ID: 10705032008433
• NIH Device Record Key: f140608c-7014-4e90-b56e-42812f0b6878
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMPO
• Version Model Number: 451512H0
• Catalog Number: 451512H0
• Company DUNS: 806136177
• Company Name: CORDIS 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705032008433 [Primary]
GS1	20705032008430 [Package]; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181836
• Premarket Notification: K991673

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-16
• Device Publish Date: 2016-08-01

On-Brand Devices [TEMPO]

• 20705032070833: F4 TEMPO 80CM 0.038 INCHESGW
• 20705032064474: 5F TEMPO 0.035 100CM 2SH JB2
• 20705032064467: 5 F TEMPO 0.038 INCHES 100CM C1
• 20705032064450: 5 F TEMPO 0.035 INCHES 65CM 2SH USL2
• 20705032064443: 5 F TEMPO .038 INCHES 65CM 2SH HNMOD
• 20705032064436: TEMPO FR 5 80 CM 0.038 INCHES
• 20705032064429: 5 F TEMPO 0.038 INCHES 100CM RH H1
• 20705032064412: F5 TEMPO 65CM 0.038 INCHES GW
• 20705032064405: CATH- TEMPO F5 100CM .035 INCHES GW
• 20705032064399: 4 F TEMPO 0.038 INCHES 110CM MAN
• 20705032064382: 4 F TEMPO 0.038 INCHES 80 CM SHK MOD
• 20705032064375: 4 F TEMPO 0.038 INCHES 80CM CONTRA I
• 20705032064368: 4 F TEMPO 0.038 INCHES 125CM SIM3
• 20705032064351: 4 F TEMPO 0.035 INCHES 125CM 5SH UF
• 20705032063354: 4F TEMPO AQUA 0.038 INCHES 120CM
• 20705032063347: 4F TEMPO AQUA 0.038 INCHES 120CM
• 20705032063095: 5F TEMPO .038 80CM HEPATIC
• 20705032052488: 5F TEMPO 0.035 INCHES 100CM 2SH STR
• 20705032052464: 5F TEMPO 0.035 INCHES 40CM BERENSTEI
• 20705032052457: 4F TEMPO 0.035 INCHES 65CM RIM
• 20705032052372: 5F TEMPO 0.035 100CM 5SH STR
• 20705032051948: 4 F TEMPO 0.038 INCHES 80CM MPA1
• 20705032051795: 5 F TEMPO .038 INCHES 100CM VISCERAL
• 20705032051788: 5 F TEMPO .038 INCHES 100CM VISCERAL
• 20705032051771: 5 F TEMPO 0.038 INCHES 125CM VERT135
• 20705032051740: 4 F TEMPO 0.038 INCHES 40CM BER II
• 20705032051733: 4 F TEMPO 0.038 INCHES 40CM JR4
• 20705032051726: 4 F TEMPO 0.038 INCHES 40CM STR
• 20705032051702: 4 F TEMPO 0.038 INCHES 125CM SIM1
• 20705032051696: 5 F TEMPO .038 INCHES 65CM VERTEBRAL
• 20705032051597: 5 F TEMPO 0.035 INCHES 125CM 5SH PIG
• 20705032051573: 5 F TEMPO 0.035 INCHES 120CM J-CURVE
• 20705032051481: 5 F TEMPO 0.038 INCHES 100CM RC MOD.
• 20705032051436: 5 F TEMPO 0.038 INCHES 100CM SRC-2
• 20705032051429: 5 F TEMPO 0.038 INCHES 100CM SRC-1
• 20705032051320: 5 F TEMPO 0.038 INCHES 100CM RH H2
• 20705032051191: 4 F TEMPO 0.038 INCHES 120 CM MANI
• 20705032051177: 5F TEMPO 0.038 INCHES 80CM C3
• 20705032051108: 5F TEMPO 0.035 125CM 5SH STR
• 20705032051092: 5 F TEMPO 0.038 INCHES 125 CM C2
• 20705032051047: 4 F TEMPO 0.038 INCHES 100CM 1 SH H1
• 20705032050958: 5F TEMPO 0.038 INCHES 110CM BL
• 20705032050811: 5 F TEMPO .038 INCHES 100CM VISCERAL
• 20705032050804: 5F TEMPO .038 INCHES 100CM VISCERAL
• 20705032050477: 5 F TEMPO 0.038 INCHES 125CM SIM1
• 20705032050460: 5 F TEMPO 0.038 INCHES 125CM BENTSON
• 20705032050194: 5F TEMPO 0.038 INCHES 65CM MS10
• 20705032050170: 5 F TEMPO 0.035 INCHES 40CM PIER
• 20705032050156: 5 F TEMPO 0.038 INCHES 80CM MS20
• 20705032050149: 5F TEMPO 0.038 INCHES 80CM MS15