SourceMark

GUDID 10813799004091

SOURCEMARK, LLC.

Circulating-air whole-body heating system control unit

• Primary Device ID: 10813799004091
• NIH Device Record Key: e3cc1cca-d7b3-4de3-a527-33c3ecfbffbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SourceMark
• Version Model Number: M21008
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813799004087 [Primary]
GS1	10813799004091 [Package]; Contains: 00813799004087; Package: Box [10 Units]; In Commercial Distribution
GS1	20813799004104 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162679

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-16
• Device Publish Date: 2020-07-08

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