RenalPure R-135

GUDID 00814963020438

ROCKWELL MEDICAL, INC.

Haemodialysis concentrate

• Primary Device ID: 00814963020438
• NIH Device Record Key: dede3706-0468-426d-8696-4c4df9d4218e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RenalPure
• Version Model Number: R-135
• Catalog Number: R-135
• Company DUNS: 933721433
• Company Name: ROCKWELL MEDICAL, INC.
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814963020438 [Primary]
GS1	10814963020435 [Package]; Package: CASE [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954527

FDA Product Code

• KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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: 2018-07-06
• Device Publish Date: 2015-09-22

On-Brand Devices [RenalPure]

• 10814963021371: C-130
• 10814963021364: C-125
• 10814963021357: C-129
• 10814963021340: C-224
• 10814963021333: C-216
• 00814963021145: R-145-55
• 00814963021008: R-140-55
• 00814963020483: R-245
• 00814963020476: R-230
• 00814963020469: R-150-55
• 00814963020452: R-145
• 00814963020445: R-140
• 00814963020438: R-135
• 00814963020421: R-134-55
• 00814963020414: R-134
• 00814963020407: R-115
• 00814963020391: R-125
• 00814963020384: R-115-55
• 00814963020377: R-116-55
• 00814963020360: R-110-55
• 00814963020353: R-110
• 00814963020346: F-220
• 00814963020339: C-132-55
• 00814963020322: C-131-55
• 00814963020308: C-126-55
• 00814963020292: C-126
• 00814963020285: C-125-55
• 00814963020278: C-124-55
• 00814963020261: C-124
• 00814963020254: C-120
• 00814963020247: C-119-55
• 00814963020230: C-117-55
• 00814963020223: C-117
• 00814963020216: C-116-55
• 00814963020209: C-116
• 00814963020193: C-114-55
• 00814963020186: C-114
• 00814963020179: C-112
• 00814963020162: C-110-55
• 00814963020155: C-110
• 00814963020148: C-108-55
• 00814963020131: C-108
• 00814963020124: C-107
• 00814963020117: C-106
• 00814963020100: C-102
• 00814963020094: RB-25-2
• 00814963020087: RB-15-4
• 00814963020070: RB-02-20
• 00814963020063: FB-25-2
• 00814963020056: CB-25-2