PURE ENRICHMENT

GUDID B311PEPULSE1

TENS UNIT

BEAR DOWN CONSULTING

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: B311PEPULSE1
• NIH Device Record Key: 43440b3d-c853-4144-a8fe-8f77c1da8a53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PURE ENRICHMENT
• Version Model Number: PEPULSE
• Company DUNS: 040869867
• Company Name: BEAR DOWN CONSULTING
• 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: 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
HIBCC	B311PEPULSE0 [Primary]
HIBCC	B311PEPULSE1 [Package]; Contains: B311PEPULSE0; Package: MASTER CARTON [20 Units]; In Commercial Distribution

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-10-19

On-Brand Devices [PURE ENRICHMENT]

• 00853975005651: neck heating pad
• 00853975005644: heating pad
• 00853975005613: neck heating pad
• 00853975005606: heating pad
• 00853975005583: Heating and cooling pad
• B311PETENSPAD5: ELECTRODE PADS
• B311PEPULSEPRO1: TENS UNIT
• B311PEPULSEDUO0: TENS & EMS UNIT
• B311PEPULSE1: TENS UNIT
• B311PEPROPAD0: PACK OF ELECTRODES
• B311PEPROBELT0: THERAPY BELT FOR BACK.
• B311PEPADBFLY1: LARGE ELECTRODE PAD
• B311PEFETDPL1: Fetal Doppler. Used to hear heart rate sounds.
• B311PEBRPUMP1: Dual electric breast pump.
• 00817387022545: PELUXWAV-S
• 00817387022538: PEPNTLUX-A
• 00817387022521: PEDESHBN
• 00817387022514: PEHPALM-A
• 00817387022507: PEHPGTREL
• 00817387022491: PEHPNVGR
• B311PEPEAK1: Massager, therapeutic, electric
• 00817387022477: PEWTPLRG-L
• 00817387022460: PEWTPSML-L
• 00817387020800: heating pad
• 00817387020732: Heating Pad for Back and Neck
• 00817387020725: heating pad
• 00817387020718: heating pad
• 00817387020688: heating and cooling lumbar pad
• 00817387020596: heating pad
• 00817387020206: Heating pad
• 00817387024075: Weighted Heating Pad
• 00817387024273: Weighted Neck Heating Pad
• 00817387025997: PEHT24RT-G
• 00817387025010: PEHPWD2-G
• 00817387026147: PECLPBK-MG
• 00817387026130: PEWDVAL-AT
• 00817387025829: PEHPVAL-RB
• 00817387025812: PEHPAD24-ZG
• 00817387026154: PECLPNE-MG
• 00817387026512: PECERDIA
• 00817387026505: PELAULVS
• 00817387026574: PEWDVAL-G
• 00817387022637: PEHTWGHT-G
• 00817387026888: PEWTVAL-MT
• 00817387022187: PEHPWIDE-SG
• 00817387022170: PEHPBACK-SG
• 00817387027465: PEHPBACK-CG
• B311PEPULSERT0: PEPULSE-RT
• B311PETNEMPD51: Wired TENS+EMS+HEAT Replacement Gel Pads
• B311PETNEMPD21: Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets