Promax OR Gowns 75670255

GUDID 00634916139297

OR GWN PROMAX KNIT AQUA L - MLR FRONT SNPS (SR 15936)

STANDARD TEXTILE CO., INC.

Surgical gown, reusable

• Primary Device ID: 00634916139297
• NIH Device Record Key: 7c4e1652-db2c-4048-ac94-f5d75c3c973e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promax OR Gowns
• Version Model Number: 75670255
• Catalog Number: 75670255
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 24
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916139297 [Primary]
GS1	10634916139297 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041540

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

[00634916139297]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-01-29

On-Brand Devices [Promax OR Gowns]

• 00634916295122: OR GWN PROMAX KAUM AQUA XL - RM (98 8282) USE: 7567P314
• 00634916295115: OR GWN PROMAX KAUM AQUA 2XL - RM (98 8282) USE: 7567P313
• 00634916294972: OR GWN PROMAX KAUM AQUA 2XL - RM (98 8282) USE: 7567P313
• 00634916189575: OR GWN PROMAX KNIT AQUA 2XL - SNPS @ NK/TT WST (SR 16518)
• 00634916147643: OR GWN PROMAX KNIT AQUA XL - SHORT MS @ NK TT WST BARCODE
• 00634916147612: OR GWN PROMAX KAUM AQUA XL - RM (98-8282) MEMORIAL HERMANN
• 00634916147599: OR GWN PROMAX KAUM AQUA 3XL - RM (98-8282) MEMORIAL HERMANN
• 00634916146622: OR GWN PROMAX KNIT AQUA 3XL - SNPS @ NK/TT WST W/BARCODE
• 00634916141870: OR GWN PROMAX KNIT AQUA 2XL - SNPS @ NK/TT WST W/BARCODE
• 00634916141863: OR GWN PROMAX KNIT AQUA XL - SNPS @ NK/TT WST W/BARCODE
• 00634916141801: OR GWN PROMAX KAUM AQUA 2XL - RM (98 6749) USE: 7567P313
• 00634916141795: OR GWN PROMAX KAUM AQUA XL - RM (98 6749) USE: 7567P314
• 00634916139310: OR GWN PROMAX KNIT AQUA 2XL - MLR FRONT SNPS TTIES @ WST
• 00634916139303: OR GWN PROMAX KNIT AQUA XL - MLR FRONT SNPS TTIES @ WST
• 00634916139297: OR GWN PROMAX KNIT AQUA L - MLR FRONT SNPS (SR 15936)
• 00634916086683: OR GWN PROMAX KNIT AQUA 2XL - MLR FRONT SNPS @ NK/TT WST
• 00634916086676: OR GWN PROMAX KNIT AQUA XL - MLR FRONT SNPS @ NK/TT WST
• 00634916086669: OR GWN PROMAX KNIT AQUA L - MLR FRONT SNPS @ NK/TT WST
• 00634916081428: OR GWN XLN PROMAX KNIT AQUA 2X - SNPS @ NK/TT WST (SR 13868)
• 00634916042528: OR GWN PROMAX KNIT AQUA L - SNPS @ NK/WST (S/R 12087)
• 00634916042511: OR GWN PROMAX KNIT AQUA XL - SNPS @ NK/WST