UNDERPAD INTEGRITY 597Y3500

GUDID 00634916336399

UNDERPAD INTEGRITY 2PLY KAUM 33X36 RM (98-8397) USE: 59782000

STANDARD TEXTILE CO., INC.

Bed sheet, reusable

• Primary Device ID: 00634916336399
• NIH Device Record Key: 448ea1a4-17ab-4e74-87b1-b4b60f8ce3d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNDERPAD INTEGRITY
• Version Model Number: 597Y3500
• Catalog Number: 597Y3500
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 24
• 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: 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: true

Customer Support Contacts

• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916336399 [Primary]
GS1	10634916336396 [Unit of Use]
GS1	10634916336399 [Unit of Use]

FDA Product Code

• FMW: Cover, Mattress (Medical Purposes)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-29

On-Brand Devices [UNDERPAD INTEGRITY]

• 00634916336399: UNDERPAD INTEGRITY 2PLY KAUM 33X36 RM (98-8397) USE: 59782000
• 00634916190359: UNDERPAD INTEGRITY 2PLY KAUM 33X36 RM (98 8049) USE: 59782000
• 00634916188400: UNDERPAD INTEGRITY 2PLY KAUM 33X36 RM (98 8129) USE: 59782000
• 00634916188219: UNDERPAD INTEGRITY 2PLY KAUM 33X36 RM (98 8132) USE: 59782000
• 00634916147261: UNDERPAD INTEGRITY KAUM 2PLY 33X36 RM (98 5659) USE: 59782000
• 00634916113457: UNDERPAD INTEGRITY 2PLY KAUM 33X36 RM (98 6408) USE: 59782000
• 00634916113129: UNDERPAD INTEGRITY 2PLY KAUM 33X36 RM (98 6408) USE: 59782000
• 00634916110746: UNDERPAD INTEGRITY 2PLY KAUM 36X41 RM (98 5659) USE: 59784000
• 00634916097238: UNDERPAD INTEGRITY 2PLY KAUM 34X36 RM (98 7693) USE: 59782000
• 00634916096200: UNDERPAD INTEGRITY 2PLY 34X36 KAUM RM (98 6433) USE: 59782000
• 00634916076127: UNDERPAD INTEGRITY 2PLY 34X36 KAUM RM (98 7507) USE: 59782000
• 00634916072969: UNDERPAD INTEGRITY 2PLY 33X36 KAUM RM (98 7471) USE: 59782000
• 00634916028317: UNDERPAD INTEGRITY 2PLY 33X36 KAUM RM (98 6879) USE: 59782000
• 00634916021776: UNDERPAD INTEGRITY 2PLY 33X36 KAUM RM (98 6856) USE: 59782000
• 00634916018004: UNDERPAD INTEGRITY 36X41 KAUM RM (98 6929) USE: 59784000
• 00634916013603: UNDERPAD INTEGRITY 2PLY 33X36 KAUM RM (98 6268) USE: 59782000
• 00634916011807: UNDERPAD INTEGRITY 2PLY 36X41 2PLY W/BLUE VINYL BARRIER
• 00634916010954: UNDERPAD INTEGRITY 2PLY 33X36 W/BLUE VINYL BARRIER