SimPro™ Set 5331200

GUDID 07333387043579

Single Use Urinary Catheter with water sachet and Accessories. Female Nelaton 8" 12FR

Wellspect AB

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 07333387043579
• NIH Device Record Key: 972ae943-d44e-4757-ae8a-8c4e7032e785
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SimPro™ Set
• Version Model Number: 5331200
• Catalog Number: 5331200
• Company DUNS: 351118942
• Company Name: Wellspect AB
• 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: true
• 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

Customer Support Contacts

• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com
• Phone: +1(877)456-3742
• Email: AnkaraTUR-Info@wellspect.com

Device Dimensions

• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333387043555 [Primary]
GS1	07333387043562 [Package]; Contains: 07333387043555; Package: [10 Units]; In Commercial Distribution
GS1	07333387043579 [Package]; Contains: 07333387043562; Package: [4 Units]; In Commercial Distribution
GS1	07392532189159 [Previous]

FDA Product Code

• NWO: Kit, catheter, urinary (exludes HIV testing)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-09
• Device Publish Date: 2024-05-01

On-Brand Devices [SimPro™ Set]

• 07333387043906: Single Use Urinary Catheter with water sachet and Accessories. Coudé 16" 16FR
• 07333387043838: Single Use Urinary Catheter with water sachet and Accessories. Coudé 16" 12FR
• 07333387043807: Single Use Urinary Catheter with water sachet and Accessories. Coudé 16" 10FR
• 07333387043784: Single Use Urinary Catheter with water sachet and Accessories. Male Nelaton 16" 16FR
• 07333387043722: Single Use Urinary Catheter with water sachet and Accessories. Male Nelaton 16" 12FR
• 07333387043593: Single Use Urinary Catheter with water sachet and Accessories. Female Nelaton 8" 14FR
• 07333387043548: Single Use Urinary Catheter with water sachet and Accessories. Fem/Ped Nelaton 8" 10FR
• 07333387043661: Single Use Urinary Catheter with water sachet and Accessories. Male Nelaton 16" 08FR
• 07333387043623: Single Use Urinary Catheter with water sachet and Accessories. Female Nelaton 8" 16FR
• 07333387043579: Single Use Urinary Catheter with water sachet and Accessories. Female Nelaton 8" 12FR
• 07333387043500: Single Use Urinary Catheter with water sachet and Accessories. Fem/Ped Nelaton 8" 08FR
• 07333387043869: Single Use Urinary Catheter with water sachet and Accessories. Coudé 16" 14FR
• 07333387043753: Single Use Urinary Catheter with water sachet and Accessories. Male Nelaton 16" 14FR
• 07333387043685: Single Use Urinary Catheter with water sachet and Accessories. Male Nelaton 16" 10FR