7070005

GUDID 10884521150485

Needle ATNAA

Cardinal Health, Inc.

Hypodermic needle, single-use
Primary Device ID10884521150485
NIH Device Record Key5d489df3-c6aa-432f-81eb-54fafd38361d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number7070005
Catalog Number7070005
Company DUNS080935429
Company NameCardinal Health, Inc.
Device Count1000
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Length1.34 Inch
Length1.34 Inch
Length1.34 Inch
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch
Device Size Text, specify0
Length1.34 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521150485 [Package]
Contains: 20884521150482
Package: CASE [4000 Units]
In Commercial Distribution
GS120884521150482 [Primary]
GS130884521150489 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, hypodermic, single lumen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number9
Public Version Date2019-10-23
Device Publish Date2016-09-24

Devices Manufactured by Cardinal Health, Inc.

20884521010830 - Monoject2025-04-02 35 mL Syringe,Catheter Tip
20884521582863 - Kangaroo2025-03-31 Nasogastric Feeding Tube with ENFit Connection
20884521582870 - Kangaroo2025-03-31 Nasogastric Feeding Tube with ENFit Connection
20884521582894 - Kangaroo2025-03-31 Nasogastric Feeding Tube
20884521582917 - Kangaroo2025-03-31 DOBBHOFF Feeding Tube
00884521065577 - Kendall2025-03-28 AMD Antimicrobial Fenestrated Foam Disc Dressing,0.5% Polyhexamethylene Biguanide HCI (PHMB)
20884521002187 - Dover2025-03-18 Urine Drainage Bag with 200 mL Meter,Needle Sampling, Twist Port Drain Tube, Poly Bag
20884521008233 - Dover2025-03-18 Irrigation Tray with Piston Syringe

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.