LifeGlobal® Media GLHP-060

GUDID 00815965020419

global HP 60 ml

LIFEGLOBAL GROUP, LLC

IVF medium

• Primary Device ID: 00815965020419
• NIH Device Record Key: 762441a3-749b-4516-9079-21a36f9a3913
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeGlobal® Media
• Version Model Number: GLHP-060
• Catalog Number: GLHP-060
• Company DUNS: 141732011
• Company Name: LIFEGLOBAL GROUP, LLC
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)720-6375
• Email: Sales@LifeGlobal.com
• Phone: +1(800)720-6375
• Email: Sales@LifeGlobal.com
• Phone: +1(800)720-6375
• Email: Sales@LifeGlobal.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815965020419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143498

FDA Product Code

• MQL: MEDIA, REPRODUCTIVE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [LifeGlobal® Media]

• 00815965020921: global Blastocyst Fast Freeze kit, 5ml vials..
• 00815965020914: global Blastocyst Fast Freeze Thawing kit, 5ml vials..
• 00815965020907: global DMSO Blast. Vitrification Warming kit..5 ml vials..
• 00815965020891: global DMSO Blastocyst Vitrification kit..5ml vials..
• 00815965020860: ALLGrad Wash 500 ml
• 00815965020853: ALLGrad Wash 100 ml
• 00815965020846: ALLGrad Wash 500 ml Glass Bottles
• 00815965020839: ALLGrad Wash 100 ml Glass Bottles
• 00815965020822: ALLGrad 100% 500 ml
• 00815965020815: ALLGrad 100% 250 ml
• 00815965020808: ALLGrad 100% 100 ml
• 00815965020792: ALLGrad 90% 100 ml
• 00815965020785: ALLGrad 90% 50 ml
• 00815965020778: ALLGrad 45% 100 ml
• 00815965020761: ALLGrad 45% 50 ml
• 00815965021379: PVP Medium, 0.2 ml vial
• 00815965020747: PVP Medium, 1 ml
• 00815965020730: Sperm Freezing, 20 ml
• 00815965020723: Sperm Freezing, 5 ml
• 00815965020716: LifeGlobal Hyaluronidase, 10 ml
• 00815965021362: LifeGlobal HSA contains 100mg/ml protein (wt/vol), 1 x 5ml
• 00815965020686: global total w/ HEPES 250 ml
• 00815965020679: global total w/ HEPES 100 ml
• 00815965020662: global total w/ HEPES 50 ml
• 00815965020655: global total For Fertilization 100 ml
• 00815965020648: global total For Fertilization 50 ml
• 00815965020631: global total For Fertilization 20 ml
• 00815965020624: global total 100 ml
• 00815965020617: global total 60 ml
• 00815965020600: global total 30 ml
• 00815965020594: global total w/ HEPES w/ HSA 250 ml
• 00815965020587: global total w/ HEPES w/ HSA 100 ml
• 00815965020570: global total w/ HEPES w/ HSA 50 ml
• 00815965020563: global total For Fertilization w/ HSA 100 ml
• 00815965020556: global total For Fertilization w/ HSA 50 ml
• 00815965020549: global total For Fertilization w/ HSA 20 ml
• 00815965020532: global total w/ HSA 100 ml
• 00815965020525: global total w/ HSA 60 ml
• 00815965020518: global total w/ HSA 30 ml
• 00815965020501: global total LP w/ HEPES 250 ml
• 00815965020495: global total LP w/ HEPES 100 ml
• 00815965020488: global total LP w/ HEPES 50 ml
• 00815965020471: global total LP For Fertilization 100 ml
• 00815965020464: global total LP For Fertilization 50 ml
• 00815965020457: global total LP For Fertilization 20 ml
• 00815965020440: global total LP 100 ml
• 00815965020433: global total LP 60 ml
• 00815965020426: global total LP 30 ml
• 00815965020419: global HP 60 ml
• 00815965020402: global HP 30 ml