Vacuette 454484

GUDID 39120049200437

VACUETTE® TUBE 4 ml Z No Additive 13x75 white cap-black ring, non-ridged

Greiner Bio-One GmbH

Evacuated blood collection tube IVD, no additive

• Primary Device ID: 39120049200437
• NIH Device Record Key: 65c9425e-e36f-4d6b-926f-539d8ac57e8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vacuette
• Version Model Number: 454484
• Catalog Number: 454484
• Company DUNS: 303639066
• Company Name: Greiner Bio-One GmbH
• Device Count: 50
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	19120049200433 [Unit of Use]
GS1	29120049200430 [Primary]
GS1	39120049200437 [Package]; Contains: 29120049200430; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK040066

FDA Product Code

• JKA: Tubes, vials, systems, serum separators, blood collection

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: 2016-09-23

On-Brand Devices [Vacuette]

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• 39120049206866: VACUETTE® TUBE 5 ml Z No Additive 13x100 white cap-black ring
• 39120049206859: VACUETTE® TUBE 3 ml Z No Additive 13x75 white cap-yellow ring, non-ridged, High Altitude
• 39120049206842: VACUETTE® TUBE 2 ml Z No Additive 13x75 black cap-yellow ring, non-ridged, High Altitude
• 39120049206835: VACUETTE® TUBE 2 ml Z No Additive 13x75 lavender cap-yellow ring, non-ridged, High Altitude
• 39120049205029: VACUETTE® Multiple Use Drawing Needle 20G x 1 1/4" yellow, sterile, not made with natural rubbe
• 39120049205012: VACUETTE® Multiple Use Drawing Needle 21G x 1 1/4" green, sterile, not made with natural rubber
• 49120049205002: VACUETTE® Multiple Use Drawing Needle 22G x 1 1/4" black, sterile, not made with natural rubber
• 39120049204831: VACUETTE® TUBE 2 ml Z No Additive 13x75 lavender cap-black ring, non-ridged, USA
• 39120049204701: VACUETTE® TUBE 5 ml Z Serum Separator Clot Activator 13x100 black cap-yellow ring, non-ridged,
• 39120049204695: VACUETTE® TUBE 4 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, non-ridged,
• 39120049204688: VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 mint green cap-yellow ring, non-ridged,
• 39120049204671: VACUETTE® TUBE 3.5 ml LH Lithium Heparin Separator 13x100 green cap-yellow ring, non-ridged, US
• 39120049204664: VACUETTE® TUBE 5 ml LH Lithium Heparin Separator 13x100 green cap-yellow ring, non-ridged, Cana
• 39120049204657: VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 red cap-yellow ring, non-ridged,
• 39120049204640: VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 black cap-yellow ring, non-ridged
• 39120049204633: VACUETTE® TUBE 4.5 ml K2E K2EDTA Separator 13x100 lavender cap-yellow ring, non-ridged, USA
• 39120049204626: VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 gold cap-gold ring, black label,
• 39120049204619: VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 gold cap-gold ring, black special
• 39120049204602: VACUETTE® TUBE 9 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged,
• 39120049204596: VACUETTE® TUBE 7 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged,
• 39120049204589: VACUETTE® TUBE 8 ml LH Lithium Heparin Separator 16x100 green cap-yellow ring, non-ridged, USA
• 39120049204572: VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 16x100 green cap-yellow ring, non-ridged, USA
• 39120049204565: VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 lavender cap-yellow ring, non-ridged, USA
• 39120049204558: VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 white cap-yellow ring, non-ridged, USA
• 39120049204541: VACUETTE® TUBE 9 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged,
• 39120049204534: VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 mint green cap-yellow ring, non-ridged,
• 39120049204527: VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 gold cap-white ring, non-ridged, USA
• 39120049204510: VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 green cap-yellow ring, non-ridged, USA
• 39120049204503: VACUETTE® TUBE 2.5 ml CAT Serum Separator Clot Activator 13x75 red cap-white ring, non-ridged,
• 39120049204497: VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 gold cap-gold ring, black label,
• 39120049204480: VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, non-ridged,
• 39120049204473: VACUETTE® TUBE 3.5 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, non-ridged,
• 39120049204466: VACUETTE® TUBE 3,5 ml K2E K2EDTA Separator 13x75 lavender cap-yellow ring, non-ridged, USA
• 39120049203384: VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich t
• 39120049201847: VACUETTE® TUBE 2 ml K3E K3EDTA 13x75 lavender cap-white ring, special label, non-ridged
• 39120049201830: VACUETTE® TUBE 4 ml CAT Serum Separator Clot Activator 13x75 red cap-yellow ring, special label
• 39120049200659: VACUETTE® TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tub
• 39120049200437: VACUETTE® TUBE 4 ml Z No Additive 13x75 white cap-black ring, non-ridged
• 39120049200345: VACUETTE® TUBE 6 ml Urine CCM 13x100 yellow cap-black ring, Round Base, non-ridged
• 39120049200314: VACUETTE® TUBE 9 ml Urine CCM 16x100 yellow cap-black ring, Conical Base, non-ridged
• 39120049200307: VACUETTE® TUBE 4 ml Urine CCM 13x75 yellow cap-black ring, Round Base, non-ridged
• 39120049200239: HOLDEX® Single-Use Holder PP single-packed, sterile, not made with natural rubber latex
• 39120049200192: VACUETTE® TUBE 9 ml CAT Serum Clot Activator 16x100 red cap-black ring, non-ridged, High Altitu
• 39120017579961: VACUETTE® TUBE 4 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-black ring, non-ridge
• 39120017579947: VACUETTE® TUBE 2 ml K2E K2EDTA 13x75 lavender cap-white ring, non-ridged, USA
• 39120017579930: VACUETTE® TUBE 3 ml K2E K2EDTA 13x75 lavender cap-black ring, special label, non-ridged,USA
• 39120017579923: VACUETTE® TUBE 4 ml K2E K2EDTA 13x75 lavender cap-black ring, non-ridged, Canada
• 39120017579886: VACUETTE® TUBE 2 ml NH Sodium Heparin Separator 13x75 green cap-green ring, non-ridged, USA
• 39120017579862: VACUETTE® TUBE 4 ml NH Sodium Heparin 13x75 green cap-green ring, non-ridged, High Altitude