SURE-LOCK 13401

GUDID 00840828146845

SURE LOCK,A34,10 PK,GREEN LEVER,CURBELL

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic electrode, reusable

• Primary Device ID: 00840828146845
• NIH Device Record Key: f30a1184-137e-4adf-b95f-c97b4b9de2cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURE-LOCK
• Version Model Number: SLC-4100-510
• Catalog Number: 13401
• Company DUNS: 796452311
• Company Name: CURBELL MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 1-800-235-7500
• Email: mwinter@curbell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840828146845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080605

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2016-09-24

On-Brand Devices [SURE-LOCK]

• 00840828179652: SURE LOCK,A34,10 PK,BLUE LEVER,CURBELL/AMBU BAG
• 00840828164948: SURE LOCK,10 PACK,BLUE,A34,CURBELL
• 00840828161978: SURE LOCK,A34,10 PK,ORANGE LEVER,CURBELL BAG,TELIC LABEL
• 00840828155830: SURE LOCK,A34,10 PK,ORANGE LEVER,CARDIOLINE
• 00840828146883: SURE LOCK,A34,10 PK,BLUE LEVER,CURBELL
• 00840828146876: SURE LOCK,A34,10 PK,ORANGE LEVER,CURBEL
• 00840828146869: SURE LOCK,A34,10 PK,RED LEVER,CURBELL
• 00840828146845: SURE LOCK,A34,10 PK,GREEN LEVER,CURBELL
• 00840828146838: SURE-LOCK,10 PACK,GREEN ,A34,CURBELL
• 00840828146326: SURE LOCK,A34,10 PK,BLUE LEVER,MIDMARK
• 00840828140683: SURELOCK, V2 -BULK ELECTRODE 50 PK
• 00840828140676: SURE-LOCK A60 5PK.CHEST LEADS W/ CURB.
• 00840828140669: SURE-LOCK A60 5PK. AHA COLORED W/ CURB.
• 00840828140652: BULK ELECTRODE,SURE-LOCK 10 SET OF 5 AH
• 00840828140645: SURELOCK, A60 5 PK, CL TAB, VB, CURBELL
• 00840828140638: SURELOCK, A60 5 PK, CL TAB, VA, CURBELL
• 00840828140621: SURELOCK V2 CONNECTOR CURB. - 5 PACK
• 00840828140614: CONNECTOR, ELECT.,SURE-LOCK, STD RT LEG
• 00840828140607: CONNECTOR, ELECT.,SURE-LOCK, STD RT ARM
• 00840828140591: CONNECTOR, ELECT.,SURE-LOCK, STD LT LEG
• 00840828140584: CONNECTOR, ELECT.,SURE-LOCK, STD LT ARM
• 00840828140577: CONNECTOR, ELECT.,SURE-LOCK, STD CHEST
• 00840828140560: CONNECTOR, ELECTRODE,SURE-LOCK,3 pack
• 00840828140553: SURE-LOCK A34,OR TAB,CURB. INSERT 10PK
• 00840828140546: SURE-LOCK A60 10PK.,LEG & CHEST,CURBELL
• 00840828131261: SURE-LOCK,10 PACK, GE DFU, GE LABEL
• 00840828131254: SURE-LOCK,14 PACK, GE DFU, GE LABEL
• 00840828127370: SURE LOCK,10 PACK,CLEAR,A60,PHILIPS