Sourcemark

GUDID 00897392002572

9 French Esophageal Stethoscope with 400 Series Thermistor Temperature Sensor - Sterile

SOURCEMARK, LLC.

General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use

• Primary Device ID: 00897392002572
• NIH Device Record Key: ff776ab0-f94f-42be-b7a7-b51c3f2382e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sourcemark
• Version Model Number: SM9400ES
• Company DUNS: 121225812
• Company Name: SOURCEMARK, LLC.
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00897392002572 [Primary]
GS1	10897392003026 [Package]; Package: case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111050

FDA Product Code

• BZT: Stethoscope, Esophageal, With Electrical Conductors

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-09
• Device Publish Date: 2019-02-19

On-Brand Devices [Sourcemark]

• 00897392002428: M0335
• 00897392002411: M0325
• 00897392002404: M0315
• 00897392002398: M0375
• 00897392002381: M0365
• 00897392002336: Tube, Endo, Oral and Nasal, Murphy, Cuffed 8.0 + Stylet, Aluminum
• 00897392002329: Tube, Endo, Oral and Nasal, Murphy, Cuffed 7.5 + Stylet, Aluminum
• 00897392002312: Tube, Endo, Oral and Nasal, Murphy, Cuffed 7.0 + Stylet, Aluminum
• 00897392002305: Tube, Endo, Oral and Nasal, Murphy, Cuffed 6.5 + Stylet, Aluminum
• 00897392002046: M1036
• 00897392002039: M1034
• 00897392002022: M1032
• 00897392002015: M1030
• 00897392002008: M1028
• 00897392001995: M1026
• 00897392001988: M1024
• 00897392001971: M1022
• 00897392001964: M1020
• 00897392001957: M1018
• 00897392001940: M1016
• 00897392001933: M1014
• 00897392001681: Tube, Endo, Nasal Preformed, Murphy, cuffed 8.0
• 00897392001674: Tube, Endo, Nasal Preformed, Murphy, cuffed 7.5
• 00897392001667: Tube, Endo, Nasal Preformed, Murphy, cuffed 7.0
• 00897392001650: Tube, Endo, Nasal Preformed, Murphy, cuffed 6.5
• 00897392001643: Tube, Endo, Nasal Preformed, Murphy, cuffed 6.0
• 00897392001636: Tube, Endo, Nasal Preformed, Murphy, uncuffed 7.0
• 00897392001629: Tube, Endo, Nasal Preformed, Murphy, uncuffed 6.5
• 00897392001612: Tube, Endo, Nasal Preformed, Murphy, uncuffed 6.0
• 00897392001605: Tube, Endo, Nasal Preformed, Murphy, uncuffed 5.5
• 00897392001599: Tube, Endo, Nasal Preformed, Murphy, uncuffed 5.0
• 00897392001582: Tube, Endo, Nasal Preformed, Murphy, uncuffed 4.5
• 00897392001575: Tube, Endo, Nasal Preformed, Murphy, uncuffed 4.0
• 00897392001568: Tube, Endo, Nasal Preformed, Murphy, uncuffed 3.5
• 00897392001551: Tube, Endo, Nasal Preformed, Murphy, uncuffed 3.0
• 00897392001537: Tube, Endo, Oral Preformed, Murphy, cuffed 8.5
• 00897392001520: Tube, Endo, Oral Preformed, Murphy, cuffed 8.0
• 00897392001513: Tube, Endo, Oral Preformed, Murphy, cuffed 7.5
• 00897392001506: Tube, Endo, Oral Preformed, Murphy, cuffed 7.0
• 00897392001490: Tube, Endo, Oral Preformed, Murphy, cuffed 6.5
• 00897392001483: Tube, Endo, Oral Preformed, Murphy, cuffed 6.0
• 00897392001452: Tube, Endo, Oral Preformed, Murphy, cuffed 4.5
• 00897392001445: Tube, Endo, Oral Preformed, Murphy, cuffed 4.0
• 00897392001438: Tube, Endo, Oral Preformed, Murphy, cuffed 3.5
• 00897392001421: Tube, Endo, Oral Preformed, Murphy, cuffed 3.0
• 00897392001407: Tube, Endo, Oral Preformed, Murphy, uncuffed 5.5
• 00897392001391: M0550U
• 00897392001384: Tube, Endo, Oral Preformed, Murphy, uncuffed 4.5
• 00897392001377: Tube, Endo, Oral Preformed, Murphy, uncuffed 4.0
• 00897392001360: Tube, Endo, Oral Preformed, Murphy, uncuffed 3.5