Cassette CRRT

Primary DI
B173SMC200
Brand
Cassette CRRT
Company
Spectral Medical Inc
Model
SM-200-001
Catalog number
SM-200-001
Device description
The Cassette for CRRT is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. The total length of the arterial and venous tubing lines are below: - Arterial patient connection line: 71 inches - Arterial dialyzer line: 20 inches - Venous patient connection line: 22 inches - Venous dialyzer line: 79 inches
Published
2018-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B173SMC200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis blood tubing set, single-useA collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18884264264gguadagni@spectraldx.com

Regulatory Flags#

DUNS number
248909939
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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B173SA400000SAMI RRT CassetteSA-400-00SA-400-002018-03-05
B173SM1000030SAMI RRTSM-100-003SM-100-0032018-02-22
B173SM2000030SAMI Hemofiltration CassetteSM-200-003SM-200-0032019-02-22
B173SA40000SAMI RRT CassetteSA-400-00SA-400-002018-03-05
B173SMF200Cassette HemofiltrationSM-200-003SM-200-0032019-02-22
B173SM001SAMI CRRT UnitSM-100-003SM-100-0032018-02-22

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