PECO

GUDID 10817668010107

Box PECO™ 7.5" Female, 16 Fr. Straight Intermittent Catheter

PECO MEDICAL INC.

Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter

• Primary Device ID: 10817668010107
• NIH Device Record Key: 782392ff-b113-44a8-9f5b-9ebad99d0d38
• Commercial Distribution Discontinuation: 2020-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PECO
• Version Model Number: PU016F
• Company DUNS: 080120792
• Company Name: PECO MEDICAL INC.
• Device Count: 30
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Length: 7.5 Inch
• Catheter Gauge: 16 French
• Length: 7.5 Inch
• Catheter Gauge: 16 French
• Length: 7.5 Inch
• Catheter Gauge: 16 French
• Length: 7.5 Inch
• Catheter Gauge: 16 French
• Length: 7.5 Inch
• Catheter Gauge: 16 French
• Length: 7.5 Inch
• Catheter Gauge: 16 French
• Length: 7.5 Inch
• Catheter Gauge: 16 French
• Length: 7.5 Inch
• Catheter Gauge: 16 French
• Length: 7.5 Inch
• Catheter Gauge: 16 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817668010100 [Unit of Use]
GS1	10817668010107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111405

FDA Product Code

• GBM: CATHETER, URETHRAL

Sterilization

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

[10817668010107]

Ethylene Oxide

[10817668010107]

Ethylene Oxide

[10817668010107]

Ethylene Oxide

[10817668010107]

Ethylene Oxide

[10817668010107]

Ethylene Oxide

[10817668010107]

Ethylene Oxide

[10817668010107]

Ethylene Oxide

[10817668010107]

Ethylene Oxide

[10817668010107]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-08-17
• Device Publish Date: 2017-09-08

On-Brand Devices [PECO]

• 10817668010572: Box PECO™ 7.5" Female, 14 Fr. Straight Intermittent Catheter
• 10817668010565: Box PECO™ 10" Pediatric, 14 Fr. Straight Intermittent Catheter
• 10817668010558: Box PECO™ 10" Pediatric, 12 Fr. Straight Intermittent Catheter
• 10817668010534: Box PECO™ 16" Male, 10 Fr. Straight Intermittent Catheter
• 10817668010527: Box PECO™ 16" Male, 8 Fr. Straight Intermittent Catheter
• 10817668010510: Box PECO™ 16" Male, 6 Fr. Straight Intermittent Catheter
• 10817668010503: Box PECO™ 10" Pediatric, 6 Fr. Straight Intermittent Catheter
• 10817668010121: Box PECO™ 7.5" Female, 8 Fr. Straight Intermittent Catheter
• 10817668010114: Box PECO™ 7.5" Female, 18 Fr. Straight Intermittent Catheter
• 10817668010107: Box PECO™ 7.5" Female, 16 Fr. Straight Intermittent Catheter
• 10817668010091: Box PECO™ 7.5" Female, 14 Fr. Straight Intermittent Catheter
• 10817668010084: Box PECO™ 7.5" Female, 12 Fr. Straight Intermittent Catheter
• 10817668010077: Box PECO™ 7.5" Female, 10 Fr. Straight Intermittent Catheter
• 10817668010060: Box PECO™ 16" Male, 18 Fr. Straight Intermittent Catheter
• 10817668010053: Box PECO™ 16" Male, 16 Fr. Straight Intermittent Catheter
• 10817668010046: Box PECO™ 16" Male, 14 Fr. Straight Intermittent Catheter
• 10817668010039: Box PECO™ 16" Male, 12 Fr. Straight Intermittent Catheter
• 10817668010022: Box PECO™ 10" Pediatric, 10 Fr. Straight Intermittent Catheter
• 10817668010015: Box PECO™ 10" Pediatric, 8 Fr. Straight Intermittent Catheter