Pro Advantage P301008

GUDID M220P3010083

Pro Advantage Gel Ultrasound Transmission 8.5 OZ 12/CS

NATIONAL DISTRIBUTION & CONTRACTING, INC.

Topical coupling gel, non-sterile

• Primary Device ID: M220P3010083
• NIH Device Record Key: 49b57963-bd5c-4b75-82cb-04daa059e144
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro Advantage
• Version Model Number: P301008
• Catalog Number: P301008
• Company DUNS: 009831413
• Company Name: NATIONAL DISTRIBUTION & CONTRACTING, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com
• Phone: 6153663225
• Email: compliance@ndc-inc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M220P3010083 [Package]; Contains: M220P3010088; Package: Case [12 Units]
HIBCC	M220P3010088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955246

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2022-06-10
• Device Publish Date: 2017-02-13

On-Brand Devices [Pro Advantage]

• M220P5495305: Pro Advantage Inflation System Thigh Latex Free
• M220P5495255: Pro Advantage Inflation System Large Adult Black Latex Free
• M220P5495155: Pro Advantage Inflation System Adult Black Latex Free
• M220P5495105: Pro Advantage Inflation System Child Black Latex Free
• M220P5492605: Pro Advantage Cuff Bladder Thigh 2 Tube Black Latex Free
• M220P5492405: Pro Advantage Cuff Bladder 2 Tube Large Adult Black Latex Free
• M220P5492203: Pro Advantage Cuff Bladder 2 Tube Adult Black Latex Free
• M220P0800145: Pro Advantage Urinalysis Reagent Strips 4 Parameter
• M220P0800125: Pro Advantage Urinalysis Reagent Strips 2 Parameter
• M220P0800103: Pro Advantage Urinalysis Reagent Strips 10 Parameter
• M220P0800073: Pro Advantage Urinalysis Reagent Strips 7 Parameter
• M220P7020105: PRO ADVANTAGE COVER SHOE NON-CONDUCTIVE BLUE 100/BX
• M220P6420003: Pro Advantage Unit Tens Digital
• M220P6410003: Pro Advantage Unit Tens Analog
• M220P0175135: Pro Advantage Pouch 7.5 X 13
• M220P0154015: Pro Advantage Pouch 5.25 X 10
• M220P0135545: Pro Advantage Pouch 3.5 X 5.25
• M220P0127905: Pro Advantage Pouch 2.75 X 9
• M220P0124245: Pro Advantage CSR Wrap 24 X 24
• M220P0120205: Pro Advantage CSR Wrap 20 X 20
• M220P0115155: Pro Advantage CSR Wrap 15 X 15
• M220P0135905: Pro Advantage Pouch 3.5 X 9
• M220P7030255: Mask face procedure earloop w/shield antifog
• M220P7030203: PA Mask Face Procedure Earloop Blue
• M220P1501305: PRO ADVANTAGE ADHSV FAB 3/4X3 100/BX 12BX/CS
• M220P1501505: PRO ADVANTAGE ADHESIVE SHEER 7/8 DIA SPOT 100/BX 12BX/CS
• M220P1501455: PRO ADVANTAGE ADHESIVE SHEER 3/4X3 100/BX 12BX/CS
• M220P1501405: PRO ADVANTAGE ADHESIVE SHEER 2X4 50/BX 12BX/CS
• M220P1501355: PRO ADVANTAGE BANDAGE ADHESIVE SHEER 1 100/BX 12BX/CS
• M220P1501255: PRO ADVANTAGE BANDAGE ADHSV FAB 2X4 50/BX 12BX/CS
• M220P1501205: PRO ADVANTAGE ADHSV FAB 1X3 100/BX 12/BXCS
• M220P15011500: PRO ADVANTAGE ADHSV FAB FINGER TIP 1-3/4X2 100/BX 12BX/CS
• M220P1501105: PRO ADVANTAGE BANDAGE ADHSV RAB KNUCKLE 1-1/2X3 100/BX 12BX/CS
• M220P1501055: PRO ADVANTAGE WOUND CLOSURE BUTTERFLY MD 100/BX 12BX/CS
• M220P54869833: Pro Advantage Suture Polypropylene Blue Mono 5-0 P-3 18
• M220P4206365: Pro Advantage Suture Chromic Cut 3-0 FS-2 27
• M220P4286615: P428661
• M220P42869986: Pro Advantage Suture Polypropylene Blue Mono 4-0 P-3 18
• M220P42869754: Pro Advantage Suture Polypropylene Blue Mono 6-0 P-1 18
• M220P42869552: Pro Advantage Suture Polypropylene Blue Mono 6-0 P-3 18
• M220P42868450: Pro Advantage Suture Polypropylene Blue Mono 3-0 FS-1 18
• M220P4286835: Pro Advantage Suture Polypropylene Blue Mono 4-0 FS-2 18
• M220P4216985: Pro Advantage Suture Nylon Black Mono 6-0 P-3 18
• M220P4216673: Pro Advantage Suture Nylon Black Mono 4-0 PS-2 18
• M220P4216665: Pro Advantage Nylon Black Mono 5-0 PS-2 18
• M220P4206993: Pro Advantage Suture Nylon Black Mono 4-0 P-3 18
• M220P4206985: Pro Advantage Suture Nylon Black Mono 5-0 P-3 18
• M220P54206975: Pro Advantage Suture Nylon Black Mono 6-0 P-1 18
• M220P4206843: Pro Advantage Suture Silk Black Braided 3-0 FS-1 18
• M220P4206835: Pro Advantage Suture Silk Black Braid 4-0 FS-2 18