SAHARA 97.8710.802

GUDID 04028339710939

Warming equipment with passive agitation plate for thawing and warming of up to 6 blood components packed in plastic bags

Transmed Medizintechnik GmbH & Co. KG

Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit Cryopreserved blood/tissue thawing unit

• Primary Device ID: 04028339710939
• NIH Device Record Key: c6eb91c9-ee49-4d14-885c-69a8c33ce950
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAHARA
• Version Model Number: SAHARA-III MAXITHERM 115V
• Catalog Number: 97.8710.802
• Company DUNS: 320762776
• Company Name: Transmed Medizintechnik GmbH & Co. KG
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04028339710939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK010045

FDA Product Code

• KZL: Device, Warming. Blood And Plasma

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: 2020-10-21
• Device Publish Date: 2016-08-15

On-Brand Devices [SAHARA]

• 04028339710939: Warming equipment with passive agitation plate for thawing and warming of up to 6 blood componen
• 04028339710236: Warming equipment with heatable agitation plate for thawing and warming of up to 3 blood compone
• 04028339720235: Thawing device for stem cell preparations