Abdominal Pressure Catheter 9F

GUDID 10627825000359

Laborie Medical Technologies Canada ULC

Urodynamic manometric catheter, non-electronic Urodynamic manometric catheter, non-electronic

• Primary Device ID: 10627825000359
• NIH Device Record Key: 79112c10-c59e-466e-adf1-34e8c8180dbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abdominal Pressure Catheter 9F
• Version Model Number: ERPC-9
• Company DUNS: 203383526
• Company Name: Laborie Medical Technologies Canada ULC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627825000352 [Primary]
GS1	10627825000359 [Package]; Contains: 00627825000352; Package: [10 Units]; In Commercial Distribution
GS1	20627825000356 [Package]; Package: [1500 Units]; In Commercial Distribution

FDA Product Code

• FEN: DEVICE, CYSTOMETRIC, HYDRAULIC

Sterilization

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

[10627825000359]

Ethylene Oxide

[10627825000359]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

On-Brand Devices [Abdominal Pressure Catheter 9F]

• 20627825000387: RPC-9
• 10627825000366: RPC-9
• 10627825000359: ERPC-9