Tru-Fix Catheter Fixation Kit TFK-10

GUDID H862TFK102

Wearable percutaneous catheter/tube holder

Primary Device ID	H862TFK102
NIH Device Record Key	ee46d0ee-9017-420c-810a-1fb2c05ea32f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Tru-Fix Catheter Fixation Kit
Version Model Number	TFK-10
Catalog Number	TFK-10
Company DUNS	192559557
Company Name	URESIL, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	H862TFK100 [Primary]
HIBCC	H862TFK101 [Package] Contains: H862TFK100 Package: Dispenser [5 Units] In Commercial Distribution
HIBCC	H862TFK102 [Package] Contains: H862TFK101 Package: Shipper [5 Units] In Commercial Distribution

KGX	Tape And Bandage, Adhesive

Steralize Prior To Use	false
Device Is Sterile	true

H862TFK162	Tru-Fix Catheter Fixation Kit - 16F
H862TFK142	Tru-Fix Catheter Fixation Kit - 14F
H862TFK122	Tru-Fix Catheter Fixation Kit - 12F
H862TFK102	Tru-Fix Catheter Fixation Kit - 10F
H862TFK082	Tru-Fix Catheter Fixation Kit - 8F
H862TFK062	Tru-Fix Catheter Fixation Kit - 6F
H862TFDR2	Tru-Fix Fixation Dressing Replacement
10817640020698	Tru-Fix Catheter Fixation Kit - 16F
10817640020681	Tru-Fix Catheter Fixation Kit - 14F
10817640020674	Tru-Fix Catheter Fixation Kit - 12F
10817640020667	Tru-Fix Catheter Fixation Kit - 10F
10817640020650	Tru-Fix Catheter Fixation Kit - 8F
10817640020643	Tru-Fix Catheter Fixation Kit - 6F
10817640020636	Tru-Fix Fixation Dressing Replacement