Revere Hybrid Access Catheter N/A

GUDID 00840303712770

Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stiffness catheter with a radiopaque zone on the distal end and a luer hub on the proximal end. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

BALT USA LLC

Vascular guide-catheter, single-use
Primary Device ID00840303712770
NIH Device Record Keyf76db604-8678-4a09-9a37-cc37f92ff9f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevere Hybrid Access Catheter
Version Model NumberREVERE6F105
Catalog NumberN/A
Company DUNS945543689
Company NameBALT USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com

Device Dimensions

Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0
Catheter Working Length105 Centimeter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light

Device Identifiers

Device Issuing AgencyDevice ID
GS100840303712770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-22
Device Publish Date2024-08-14

On-Brand Devices [Revere Hybrid Access Catheter]

00840303712770Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
00840303712763Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
00840303712756Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
00840303712749Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
00840303712732Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
00840303712725Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
00840303712718Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
00840303712701Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
00840303712695Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif

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