Sensoronics

GUDID 00851456007477

SENSORONICS INCORPORATED

Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use Pulse oximeter probe, single-use

• Primary Device ID: 00851456007477
• NIH Device Record Key: e3273362-83f9-495d-a3fc-16c2688e0c15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensoronics
• Version Model Number: SFP-NCR-36N
• Company DUNS: 079579147
• Company Name: SENSORONICS INCORPORATED
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851456007477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113727

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [Sensoronics]

• 00851457007261: SB-NCRON-3P
• 00851457007254: SC-PH-8RH
• 00851457007247: SC-SPNE-8REC
• 00851457007230: SC-SPNE-8HYP
• 00851457007223: SC-PHOXNE-8RH
• 00851457007216: SC-PHOXNE-8HH
• 00851457007209: SC-PH-8H
• 00851457007193: SC-OXDOC-8
• 00851457007186: SC-OX-8
• 00851457007179: SC-OX-4
• 00851457007162: SC-NESCP-8
• 00851457007155: SC-MAR-5LNC
• 00851457007148: SC-MA-4LNC
• 00851457007131: SC-MA-10LNC
• 00851457007124: SC-GEOX-8
• 00851457007117: SC-GEOH-8
• 00851457007100: SC-GENE-8
• 00851457007094: SC-GEMAS-8
• 00851457007087: SC-GEMA-8
• 00851457007070: SC-OXNE-8
• 00851457007063: SC-OXNE-4
• 00851457007056: SC-MARNE-5
• 00851457007049: SC-MANE-8LNC
• 00851457007032: SC-MANE-8AMP
• 00851457007025: SC-MANE-4LNC
• 00851457007018: SC-GEMANE-8
• 00851457007001: SRP-OHM-9P
• 00851456007996: SRP-OHM-9A
• 00851456007989: SRP-OHM-3P
• 00851456007972: SRP-OHM-3A
• 00851456007965: SRP-NON-3P
• 00851456007958: SRP-NON-3A
• 00851456007941: SRP-NCRO-9P
• 00851456007934: SRP-NCRO-9A
• 00851456007927: SRP-NCRO-3P
• 00851456007910: SRP-NCRO-3A
• 00851456007903: SRP-MALNC-3P
• 00851456007897: SRP-MALNC-3A
• 00851456007880: SRP-BCI-3P
• 00851456007873: SRP-BCI-3A
• 00851456007774: SFP-BCI-18A
• 00851456007729: SECG-PHY6L-3
• 00851456007712: SECG-PHY12L-TC8
• 00851456007705: SECG-PHY12L-TC5
• 00851456007699: SECG-PHP5L-TC1668
• 00851456007682: SECG-PHP5L-TC1600
• 00851456007675: SECG-PHP5L-TC1520
• 00851456007668: SECG-PHP5L-1968
• 00851456007651: SECG-PHP5L-1644
• 00851456007644: SECG-PHP5L-1625