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Adherent Bag

FDA UDI

Class I (US FDA UDI)

by Scinus Cell Expansion Netherlands B.V.

Identity

Trade Name
Adherent Bag FDA UDI
Generic Name
Blood/tissue storage/culture container FDA UDI
Device Name
For the adherent cell culture inside the SCINUS the Adherent Bag is used. This Adherent Bag is intended exclusively for use with the SCINUS. The SCINUS is a closed, controlled bioreactor system for automated cell cultivation. Combined with the Adherent Bag, it allows large-fold cell expansion without passing the cells due to its unique expansion technology. The SCINUS is operated by a controller, which is accessible through an integrated graphical user interface (GUI). The unique combination of the rocker, roller, and Adherent Bag ensures a homogenous environment with minimal levels of shear forces. The roller on top of the rocker enables the expansion of the available culture volume and surface area. The pH and dissolved oxygen (DO) levels are measured by integrated sensors in the Adherent Bag and are controlled with the controller software. The carboxygenator ensures that the set points are maintained within the desired bandwidths. For the culture of adherent cells, the Adherent Bag must be installed in the SCINUS. The Adherent Bag contains the culture bag and the corresponding weldable tubing set. One of the unique features of the Adherent Bag is the gradual expansion of the cell culture volume. The volume can be increased from a minimal volume of 0.1 L to 1.4 L to accommodate the growing cell population. FDA UDI
Model / Reference
ADH-01-01 FDA UDI
Description
For the adherent cell culture inside the SCINUS the Adherent Bag is used. This Adherent Bag is intended exclusively for use with the SCINUS. The SCINUS is a closed, controlled bioreactor system for automated cell cultivation. Combined with the Adherent Bag, it allows large-fold cell expansion without passing the cells due to its unique expansion technology. The SCINUS is operated by a controller, which is accessible through an integrated graphical user interface (GUI). The unique combination of the rocker, roller, and Adherent Bag ensures a homogenous environment with minimal levels of shear forces. The roller on top of the rocker enables the expansion of the available culture volume and surface area. The pH and dissolved oxygen (DO) levels are measured by integrated sensors in the Adherent Bag and are controlled with the controller software. The carboxygenator ensures that the set points are maintained within the desired bandwidths. For the culture of adherent cells, the Adherent Bag must be installed in the SCINUS. The Adherent Bag contains the culture bag and the corresponding weldable tubing set. One of the unique features of the Adherent Bag is the gradual expansion of the cell culture volume. The volume can be increased from a minimal volume of 0.1 L to 1.4 L to accommodate the growing cell population. FDA UDI

Identifiers

Primary DI / UDI-DI
08720299213616 FDA UDI
FDA Product Code
KJF FDA UDI
GMDN Term
Blood/tissue storage/culture container FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.2240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Blood/tissue storage/culture container

Adherent Bag by Scinus Cell Expansion Netherlands B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood/tissue storage/culture container.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scinus Cell Expansion Netherlands B.V.

Sources (1)

  • FDA UDI 06c8caaf-7233-48a2-8105-3f13f5467f17 33 fields · synced May 30, 2026