Halyard 79612

GUDID 30680651796128

HALYARD* ULTRA* SMS & Film Surgical Gown, Zoned Impervious-X-Large-Handi-Bin-480

O&M HALYARD, INC.

Surgical gown, single-use

• Primary Device ID: 30680651796128
• NIH Device Record Key: 2559dbad-63f7-4683-b027-6bad00f084f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halyard
• Version Model Number: 79612
• Catalog Number: 79612
• Company DUNS: 081057389
• Company Name: O&M HALYARD, INC.
• Device Count: 40
• 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com
• Phone: +1(844)425-9273
• Email: PIQ@hyh.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10680651796124 [Primary]
GS1	30680651796128 [Package]; Contains: 10680651796124; Package: CS [12 Units]; In Commercial Distribution
GS1	90680651796120 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K842115

FDA Product Code

• KKX: Drape, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-10-02

On-Brand Devices [Halyard]

• 30680651915123: SURGICAL REINFORCED GOWN LARGE 40
• 30680651799709: STANDARD GOWN LARGE 44
• 30680651798818: HYH OEM STOCKINETTE LGE
• 30680651798610: HYH OEM STOCKINETTE
• 30680651798351: SURGICAL DRAPE 14
• 30680651798313: HALYARD* SURGICAL SURGICAL GOWN 45
• 30680651798283: SURGICAL ABSORBENT DRAPE 54
• 30680651798108: ABDOM SHT 38X60
• 30680651797903: HYHL100 TOP DRAPE 275X150CM
• 30680651797880: HYHL100 U-DRAPE 193X305 W/30X76CM SPLIT
• 30680651797873: HYHL100 BOTTOM DRAPE 195X195CM
• 30680651797866: HYHL100 BODY SPLIT DRAPE 254X168CM
• 30680651797842: HYHL100 VARIABLE FENESTRATED DRAPE W/TAPE 75X100CM
• 30680651797835: HYHL100 UTILITY DRAPE W/TAPE 90X90CM
• 30680651797828: HYHL100 UTILITY DRAPE 90X90 CM
• 30680651797811: SURGICAL NONSTERILE SLEEVE 100
• 30680651797606: HYHL100 BODY SPLIT DRAPE 120
• 30680651797590: HYHL100 SHOULDER SPLIT DRAPE 120
• 30680651797583: HYH,ARTHRO,SHLDR,-,-,50
• 30680651797576: HYH,BODY,SPLDRP,-,88X116,30
• 30680651797569: HYHL100 SIDE DRAPE 76X44 120
• 30680651797552: HYHL100 BOTTOM DRAPE 76X76 120
• 30680651797545: HYHL100 TOP DRAPE 108X50 120
• 30680651797477: HYHL100 FENESTRATED DRAPE 76X76CM, 3X5CM RECTANGULAR
• 30680651797460: HYHL100 FENESTRATED DRAPE W/TAPE, 50X75CM
• 30680651797453: HYHL100 FENESTRATED DRAPE 211X241, 12CM ROUND
• 30680651797422: HYHL100 CYSTOSCOPY DRAPE 30
• 30680651797316: UTILITY DRAPE W/TAPE 550
• 30680651797118: SURGICAL FEMRL-ANGIO DRAPE 18
• 30680651797095: SURG F-A DRAPE XLNG 16
• 30680651796975: HYHL100 PERINEAL COVER DRAPE W/TAPE 15X40CM
• 30680651796968: HYHL100 LARGE DRAPE 152X193CM
• 30680651796951: HYHL100 HAND & FOOT DRAPE 200X300CM CONFORMABLE 3CM FENESTRATION
• 30680651796944: HYHL100 HALF DRAPE, 112X152CM
• 30680651796937: HYHL100 FENESTRATED DRAPE 90X90CM, 10CM ROUND
• 30680651796920: HYHL100 FENESTRATED DRAPE 90X90CM, 10CM ROUND
• 30680651796913: HYHL100 FENESTRATED DRAPE 76X76CM 7X10CM OVAL
• 30680651795992: HYHL100 LAPAROSCOPY DRAPE 60
• 30680651795978: HYHL100 EENT SPLIT DRAPE 60
• 30680651795954: HYHL100 LEGGINGS CLEAR 120
• 30680651795930: HYHL100 UNIVERSAL DRAPE 40
• 30680651795848: HYHL100 BUTTOCK DRAPE W/POUCHES 120
• 30680651795800: HYH,SIDE,DRAPE,-,44X76,40
• 30680651795718: HYH,TOP,DRAPE,-,50X108,32
• 30680651795619: HYH,BTM,DRAPE,-,76X76,20
• 30680651795480: HYH,CYSTOT,SHT,-,-,36
• 30680651795459: CYSTO W/LEG SHEETS 87X100 20
• 30680651795381: HYHL100 LAP CHOLY DRAPE 60
• 30680651795336: HYHL100 BAR DRAPE 80
• 30680651795312: HYHL100 FENESTRATED DRAPE 60