WAFFLE 1005ECPX010

GUDID 10603354100210

1005ECP WAFFLE EXPANSION CONTROL PLUS MATTRESS PAD W/PMP - SNGL

EHOB INC

Air-filled bed mattress overlay

• Primary Device ID: 10603354100210
• NIH Device Record Key: 50ef3bbf-1806-4f1a-94e3-c035bc89d0a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAFFLE
• Version Model Number: REV00
• Catalog Number: 1005ECPX010
• Company DUNS: 150600252
• Company Name: EHOB INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603354100210 [Primary]
GS1	30603354100702 [Package]; Package: Box [6 Units]; In Commercial Distribution

FDA Product Code

• IKY: Mattress, Flotation Therapy, Non-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-31
• Device Publish Date: 2020-08-21

On-Brand Devices [WAFFLE]

• 30603354300683: 505TPU FOOT WAFFLE EXTENDED CARE CUSTOM - LARGE - SNGL
• 30603354300669: 504TPU FOOT WAFFLE EXTENDED CARE CUSTOM - MEDIUM - SNGL
• 30603354300645: 503TPU FOOT WAFFLE EXTENDED CARE CUSTOM - SMALL - SNGL
• 30603354300621: 545CV WAFFLE CUSTOM HEEL ELEVATOR - ONE SIZE W/ ANTI-ROTATION WEDGE - SNGL
• 30603354300607: 545CV WAFFLE CUSTOM HEEL ELEVATOR - ONE SIZE - SNGL
• 30603354300584: ANTI-ROTATION WEDGE (LARGE) - SNGL
• 30603354300553: ANTI-ROTATION WEDGE (SMALL) - SNGL
• 30603354300522: ANTI-ROTATION WEDGE (MEDIUM) - SNGL
• 30603354300492: 545TPU WAFFLE CUSTOM EXTENDED CARE HEEL ELEVATOR - ONE SIZE - SNGL
• 30603354300478: 545CX WAFFLE CUSTOM HEEL ELEVATOR - ONE SIZE W/ ANTI-ROTATION WEDGE - SNGL
• 30603354300454: 545CX WAFFLE CUSTOM HEEL ELEVATOR - ONE SIZE - SNGL
• 30603354300430: 505FW FOOT WAFFLE CUSTOM - LARGE W/ ANTI-ROTATION WEDGE - SNGL
• 30603354300416: 505FW FOOT WAFFLE CUSTOM- LARGE - SNGL
• 30603354300393: 504FW FOOT WAFFLE CUSTOM - MEDIUM W/ ANTI-ROTATION WEDGE - SNGL
• 30603354300379: 504FW FOOT WAFFLE CUSTOM - MEDIUM - SNGL
• 30603354300355: 503FW FOOT WAFFLE CUSTOM - SMALL W/ ANTI-ROTATION WEDGE - SNGL
• 30603354300331: 503FW FOOT WAFFLE CUSTOM - SMALL - SNGL
• 30603354300317: 345TPU WAFFLE EXTENDED CARE HEEL ELEVATOR - ONE SIZE - SNGL
• 30603354300294: 345CX WAFFLE HEEL ELEVATOR - ONE SIZE - SNGL
• 30603354300270: 305FW FOOT WAFFLE AIR CUSHION - LARGE - SNGL
• 30603354300256: 304FW FOOT WAFFLE AIR CUSHION - MEDIUM - SNGL
• 30603354300232: 303FW FOOT WAFFLE AIR CUSHION - SMALL - SNGL
• 10603354201603: 205TPUP WAFFLE EXTENDED CARE MULTI-CARE PAD W/LAD - SNGL
• 10603354201573: 205TPU WAFFLE PREINFLATED EXTENDED CARE MULTI-CARE PAD - SNGL
• 10603354201542: 205TPU WAFFLE EXTENDED CARE MULTI-CARE PAD - SNGL
• 10603354201511: 205WP WAFFLE MULTI-CARE PAD W/LAD - SNGL
• 10603354201481: 205WP WAFFLE PREINFLATED MULTI-CARE PAD - SNGL
• 10603354201450: 205WP WAFFLE MULTI-CARE PAD - SNGL
• 10603354201429: 201TPU WAFFLE EXTENDED CARE MULTI-CARE PAD W/LAD - SNGL
• 10603354201399: 201TPU WAFFLE PREINFLATED EXTENDED CARE MULTI-CARE PAD - SNGL
• 10603354201368: 201TPU WAFFLE EXTENDED CARE MULTI-CARE PAD - SNGL
• 10603354201344: 240WC WAFFLE VALVELESS EXTENDED CARE BARIATRIC CUSHION COVER- SINGLE
• 10603354201306: 228WC WAFFLE VALVELESS EXTENDED CARE CUSHION COVER - SNGL
• 10603354201269: 210WC WAFFLE VALVELESS EXTENDED CARE CUSHION COVER - SNGL
• 30603354201218: 240WC WAFFLE VALVELESS EXTENDED CARE BARIATRIC CUSHION - SNGL
• 10603354201177: 228WC WAFFLE VALVELESS EXTENDED CARE CUSHION - SNGL
• 10603354201146: 210WC WAFFLE VALVELESS EXTENDED CARE CUSHION - SNGL
• 10603354200910: 228WC WAFFLE PREINFLATED EXTENDED CARE CUSHION - SNGL
• 10603354200644: 2100WCXXCOV
• 10603354200637: 210WC WAFFLE PREINFLATED EXTENDED CARE CUSHION W/COVER - SNGL
• 10603354200620: 210WC WAFFLE PREINFLATED EXTENDED CARE CUSHION - SNGL
• 10603354200606: 201WP WAFFLE PREINFLATED MULTI-CARE PAD - SNGL
• 10603354200590: 207GDC WAFFLE CHAIR PAD COVER - SNGL
• 10603354200545: 240WC WAFFLE EXTENDED CARE BARIATRIC CUSHION COVER - SNGL
• 10603354200538: 228WC WAFFLE EXTENDED CARE CUSHION COVER - SNGL
• 10603354200521: 218WC WAFFLE STANDARD ADULT CUSHION COVER - SNGL
• 10603354200514: 201WP WAFFLE MULTI-CARE PAD COVER - SNGL
• 10603354200507: 200WC WAFFLE ORIGINAL CUSHION W/COVER - SNGL
• 30603354200983: 240WC WAFFLE PREINFLATED EXTENDED CARE BARIATRIC CUSHION W/COVER - SNGL
• 30603354200969: 240WC WAFFLE PREINFLATED EXTENDED CARE BARIATRIC CUSHION - SNGL