MABIS 15-639-000

GUDID 10767056156392

BASAL DIGITAL THERMOMETER W/BEEPER & MEMORY WATERPROOF

D-M-S HOLDINGS, INC.

Continuous electronic patient thermometer, battery-powered

• Primary Device ID: 10767056156392
• NIH Device Record Key: 13b21a2a-1d95-4492-a756-ae8e0a860785
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MABIS
• Version Model Number: 15-639-000
• Catalog Number: 15-639-000
• Company DUNS: 062028220
• Company Name: D-M-S HOLDINGS, INC.
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00767056156395 [Primary]
GS1	10767056156392 [Package]; Contains: 30767056156396; Package: Master Carton [12 Units]; In Commercial Distribution
GS1	30767056156396 [Package]; Contains: 00767056156395; Package: Inner Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962520

FDA Product Code

• OZK: Thermometer, Exhaled Breath

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: 2016-09-23

On-Brand Devices [MABIS]

• 00767056969216: LATEX-FREE LEGACY ADJUSTABLE MOBILE SPHYG W/WEIGHTD BASE BLACK ADULT
• 10767056968117: LATEX-FREE LEGACY ADJUSTABLE MOBILE ANEROID SPHYG W/NYLON CUFF BLUE ADULT
• 10767056966212: LATEX-FREE LEGACY ADJUSTABLE WALL CLOCK ANEROID SPHYG W/NYLON CUFF BLACK ADULT
• 10767056966113: LATEX-FREE LEGAGY ADJUSTABLE WALL CLOCK ANEROID SPHYG W/NYLON CUFF BLUE ADULT
• 10767056830230: BLADDER ONLY 2-TUBE INFANT
• 10767056830216: BLADDER ONLY 2-TUBE ADULT
• 10767056740119: CUFF BLUE NYLON ADULT
• 00767056705159: MABIS ZOOTEMPS ANIMAL CHARACTER THERMOMETERS
• 10767056690162: NYLON CUFF W/1 TUBE BLADDER BLUE LARGE ADULT
• 10767056690117: NYLON CUFF W/1-TUBE BLADDER BLUE ADULT
• 10767056650050: DELUXE EMT KIT
• 10767056601618: CUFF & BLADDER 2-TUBE BLUE NYLON LARGE ADULT
• 10767056601519: CUFF & BLADDER 2-TUBE BLUE NYLON CHILD
• 10767056600116: CUFF & BLADDER 2-TUBE BLUE NYLON ADULT
• 10767056015514: MEDIC-KIT5 EMT KIT ORANGE
• 10767056015507: MEDIC-KIT5 EMT KIT BLUE
• 10767056550114: CALIBER PALM ANEROID W/NYLON CUFF BLUE ADULT
• 10767056410173: LATEX-FREE PRECISION ANEROID SPHYG W/NYLON CUFF BLUE THIGH
• 10767056410166: LATEX-FREE PRECISION ANEROID SPHYG W/NYLON CUFF BLUE LARGE ADULT
• 10767056410159: LATEX-FREE PRECISION ANEROID SPHYG W/NYLON CUFF BLUE CHILD
• 10767056410111: LATEX-FREE PRECISION ANEROID SPHYG W/NYLON CUFF BLUE ADULT
• 10767056403908: COSMO COMP NEBULIZER
• 10767056403748: MEDICATION CUPS FOR 40-370-000
• 10767056403694: DIGGER DOG PEDIATRIC NEBULIZER W/CASE
• 10767056403663: NEBPAK GIRL ULTRASONIC NEBULIZER
• 10767056403656: NEBPAK BOY ULTRASONIC NEBUILIZER
• 10767056403113: AIR FILTERS FOR 40-370
• 10767056403069: MOUTHPIECE FOR 40-370-000
• 10767056402758: EXTENSION TUBE FOR 40-370-000
• 10767056402697: MARGO MOO COMPRESSOR NEBULIZER W/CASE
• 10767056401782: AIR FILTERS FOR 40-136-000
• 10767056401775: 12-VOLT RECHARGEABLE FOR 40-136FOR 40-135/136
• 10767056401362: COMPXP COMPRESSOR NEBULIZER W/CASE & ACCESSORIES
• 10767056401263: MINICOMP COMPRESSOR NEBULIZER W/CASE
• 10767056401256: MINICOMP COMPRESSOR NEBULIZER
• 10767056401126: ANGLED MOUTHPIECE KIT COMPMIST
• 10767056401119: AIR FILTERS
• 10767056401096: TEE ADAPTER NEBULIZER KIT
• 10767056401089: BABY PACIFIER NEBULIZER KIT COMPMIST BABY
• 10767056401065: ANGLED MOUTHPIECE
• 10767056401058: COMPMIST COMPRESSOR NEBULIZER
• 10767056401027: 7 TUBING ONLY FOR ALL MABIS COMPRESSOR NEBS
• 10767056401010: NEBULIZER ONLY FOR ALL MABIS COMPRESSOR NEBS
• 10767056400174: PRECISION ANEROID SPHYG W/NYLON CUFF BLUE THIGH
• 10767056400167: PRECISION ANEROID SPHYG W/NYLON CUFF BLUE LARGE ADULT
• 10767056400150: PRECISION ANEROID SPHYG W/NYLON CUFF BLUE CHILD
• 10767056400136: PRECISION ANEROID SPHYG W/NYLON CUFF BLUE INFANT
• 10767056400112: PRECISION SPHYG ADULT WITH BLUE NYLON CUFF
• 10767056400082: REUSABLE NEBULIZER KIT
• 10767056365213: MATCH MATES SPHYG W/SPRAGUE RAPPOPORT SCOPE IN FANNY PACK ROYAL BLUE ADULT