BREG C00020-NL

GUDID 00672736065167

BREG, INC.

Inflatable hot/cold therapy pack/electric pump

• Primary Device ID: 00672736065167
• NIH Device Record Key: 84333da6-542d-46eb-931c-8efaed068bf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BREG
• Version Model Number: VPULSE THERM COMP PAD BACK NO LNR
• Catalog Number: C00020-NL
• Company DUNS: 604483321
• Company Name: BREG, 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: true
• 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: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx
• Phone: 8003210607
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00672736065167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122640

FDA Product Code

• JOW: Sleeve, Limb, Compressible

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: 2019-02-06
• Device Publish Date: 2016-08-15

On-Brand Devices [BREG]

• 00672736126776: AUTO ADAPTER COLD THERAPY
• 00672736126769: POLAR CARE Y ADAPTOR (6')
• 00672736112731: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10225 I-Flo Shoulde
• 00672736112724: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10220 I-Flo Shoulde
• 00672736112717: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10245 I-Flo MU Long
• 00672736112700: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10240 I-Flo MU Pad
• 00672736112694: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10230 I-Flo Knee Pa
• 00672736112687: NOVAPLUS POLAR PAD M/U
• 00672736112670: NOVAPLUS POLAR PAD KNEE/SHLDR
• 00672736112663: NOVAPLUS WO PAD SHLDR XL
• 00672736112656: NOVAPLUS WO PAD SHLDR
• 00672736112649: NOVAPLUS WO PAD M/U LS XL
• 00672736112632: NOVAPLUS WO PAD M/U XL
• 00672736112625: NOVAPLUS WO PAD KNEE XL
• 00672736112618: NOVAPLUS WO KNEE L
• 00672736112601: NOVAPLUS WO PAD KNEE
• 00672736112588: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 04905 WO XL Shoulde
• 00672736112571: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 04900 WO Shoulder P
• 00672736112564: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 04740 WO XL Lng MU
• 00672736112557: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 04705 WO XL Knee Po
• 00672736112540: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 04703 WO Large Knee
• 00672736112526: 1 Ice Water Container and 1 6 VDC output, 120 VAC 60 Hz input transformer
• 00672736065303: VPULSE THERM PAD ANKL
• 00672736065167: VPULSE THERM COMP PAD BACK NO LNR
• 00672736065150: BREG COLD COMPRESSION PAD, BACK
• 00672736065112: BREG COLD COMPRESSION PAD, KNEE
• 00672736065099: BREG COLD COMPRESSION PAD, UNIVERSAL
• 00672736065068: VPULSE THERM CMP PAD HIP NO LNR
• 00672736065051: BREG COLD COMPRESSION PAD, HIP
• 00672736064986: VPULSE SEQ COMP PAD (2)
• 00672736064979: BREG COLD COMPRESSION PAD, FOOT/ANKLE
• 00672736064962: BREG COLD COMPRESSION PAD, SHOULDER
• 00672736064955: VPULSE THRM CMP PAD KNEE L NO LNR
• 00672736064948: BREG COLD COMPRESSION PAD, KNEE L
• 00672736064825: 1 Ice Water Container, 1 12 VDC, 24W output 100-240V 50/60 Hz input transformer and 2 Sequential
• 00672736064818: 1 Ice Water Container, 1 12 VDC, 24W output 100-240V 50/60 Hz input transformer
• 00672736031162: WRAPON PAD, HIP
• 00672736031155: 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer and 1 04750 WO Hip Pol
• 00672736031148: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 04750 WO Hip Polar
• 00672736022313: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10220 I-Flo Shoulde
• 00672736022306: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10245 I-Flo MU Long
• 00672736022290: 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 10240 I-Flo MU Pad
• 00672736022283: 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer
• 00672736022191: TOPSHELF WRAP BACK L
• 00672736022184: TOPSHELF WRAP BACK M
• 00672736022177: TOPSHELF WRAP SHDLR L/XL
• 00672736022160: TOPSHELF WRAP SHDLR S/M
• 00672736021804: 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer and 1 04730 WO Ankle P
• 00672736021798: 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer and 1 04905 WO XL Shou
• 00672736021781: 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer and 1 04900 WO Shoulde