FDA-Device2018-04-18Class II
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH
Arrow International Inc
Hazard
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Sold states
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1335-2018Don't want to check this manually?
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