Tech-Med 2010X

GUDID 20665973017000

DELUXE SPHYG. BLACK, LG. ADULT

DUKAL CORPORATION

Blood pressure cuff, reusable

• Primary Device ID: 20665973017000
• NIH Device Record Key: 62b6c52d-becb-491a-a770-db0e681dfa20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tech-Med
• Version Model Number: 2010X
• Catalog Number: 2010X
• Company DUNS: 791014871
• Company Name: DUKAL CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00665973017006 [Primary]
GS1	10665973017003 [Package]; Contains: 00665973017006; Package: Box [12 Units]; In Commercial Distribution
GS1	20665973017000 [Package]; Contains: 00665973017006; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780715

FDA Product Code

• DXQ: blood pressure cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Tech-Med]

• 20665973017116: CM4560 Electrode
• 20665973017093: Thermometer Probe Covers
• 20665973017086: Dig. Therm, Dual Scale
• 20665973017079: Delux Chrome Sphyg Black Nylon
• 20665973017062: Delux Chrome Sphyg Black Nylon
• 20665973017055: Standard Sphyg., Nylon Black, Lg. Adult Latex Free
• 20665973017048: Standard Sphyg., Cotton Black, Child Latex Free
• 20665973017031: Standard Sphyg., Nylon Black, Lg. Adult Latex Free
• 20665973017024: Standard Sphyg., Nylon Black, Thigh Latex Free
• 20665973017017: Standard Sphyg., Nylon Black, Child Latex Free
• 20665973017000: DELUXE SPHYG. BLACK, LG. ADULT
• 20665973016997: DELUXE SPHYG. BLACK CHILD
• 20665973016980: Manometer, Chrome
• 20665973016973: Manometer, Black
• 20665973016966: Delux Chrome Sphyg Black Nylon
• 20665973016959: Standard Sphyg., Nylon Black w/D-ring, Adult Latex Free,stethosope attached
• 20665973016942: Standard Sphyg., Nylon Black w/D-ring, Adult Latex Free
• 20665973016935: Standard Sphyg., Cotton Black, Adult Latex Free
• 20665973016928: Standard Sphyg., Nylon Black, Adult Latex Free
• 20665973016911: DELUXE SPHYG. BLACK ADULT
• 20665973016904: BP Kit, 22"Sprague, Teal
• 20665973016898: BP Kit, 22"Sprague, Navy
• 20665973016881: BP Kit, 22"Sprague, Light Blue
• 20665973016874: BP Kit, 22"Sprague, black
• 20665973016867: Black Nylon cuff , 2Tb ,Latex Free, Lg adult
• 20665973016850: Black Nylon cuff , 2Tb ,Latex Free, Thigh
• 20665973016843: Black Nylon cuff , 2Tb ,Latex Free, Infant
• 20665973016836: Black Nylon cuff , 2Tb ,Latex Free, Child
• 20665973016829: Black Nylon cuff , 2Tb ,Latex Free, Adult
• 20665973016812: FA5050 Electrode
• 20665973016799: GM3A50T Analog TENS
• 20665973016782: GM3A50T(0) Analog TENS
• 20665973016775: GM3A50E Analog EMS