BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

SynGenX®-1000

DI: B039SGI03050 · Model: SGI-0305 · Thermogenesis Corp.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: SynGenX®-1000
Primary DI: B039SGI03050
Version / Model: SGI-0305
Company Name: Thermogenesis Corp.
Labeler DUNS: 080690327
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-24
Public Version: 6
Public Version Date: 2021-10-13
Public Version Status: Update
Public Device Record Key: 2e68f3a9-9295-4066-8dd1-b50966182bcd

Device Description

SynGenX®-1000 Disposable Cartridge

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAO	Cord Blood Processing System And Storage Container	Hematology	864.9900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47115	Umbilical cord blood collection set	A group of devices intended to be used to collect, process, and store umbilical cord blood and/or umbilical cord blood components (e.g., buffy coat). It typically includes tubing, hollow needles for insertion into the umbilical cord (a double venipuncture of the cord) to collect the blood, and several containers (flexible bags usually containing an anticoagulant) intended for transitional (room temperature) or long-term (frozen) blood storage. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukaemia. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B039SGI03050	HIBCC
Package	B039SGI03051	HIBCC		36	In Commercial Distribution
Package	B039SGI03059	HIBCC		11	In Commercial Distribution

Customer Contacts

Phone: 8443630709
Email: [email protected]

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 10 – 35 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 10 – 95 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: 7 – 50 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 95 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal