DEVICE: K-Pack II (05413206216734)

Device Identifier (DI) Information

K-Pack II
KN-2719RB500P
In Commercial Distribution
KN-2719RB500P
Terumo Europe NV
05413206216734
GS1

1
370193559 *Terms of Use
K-Pack II Needle
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Hypodermic needle, single-use, sterile A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes, secondary medication sets, or phlebotomy equipment (e.g., blood collection adapters or holders) to prepare and administer fluids/medications/drugs to a patient and/or to withdraw(aspirate) fluids from a patient. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FMI Needle, Hypodermic, Single Lumen
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not store at extreme temperature and humidity
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Needle Outer Diameter: 0.4 Millimeter
Device Size Text, specify: Needle Length: 20 Millimeter
Device Size Text, specify: Needle Length: 0.75 Inch
Needle Gauge: 27 Gauge
CLOSE

Device Record Status

b468c289-f2bb-4d62-a07e-804f033969c3
March 29, 2018
2
October 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
55413206216739 10 35413206216735 In Commercial Distribution Carton
35413206216735 500 05413206216734 In Commercial Distribution Shelfbox
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
CLOSE