DEVICE: K-Pack II (05413206042319)

Device Identifier (DI) Information

K-Pack II
KN-2913RBKT
In Commercial Distribution
KN-2913RBKT
Terumo Europe NV
05413206042319
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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
59230 Hypodermic needle, single-use
A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
Active false
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K082820 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.
Storage Environment Temperature: between 2 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Needle Outer Diameter: 0.33 Millimeter
Device Size Text, specify: Thin Wall
Device Size Text, specify: Needle Length: 12 Millimeter
Device Size Text, specify: Needle Length: 0.5 Inch
Needle Gauge: 29 Gauge
CLOSE

Device Record Status

518ab54d-98d4-48f7-b2ba-16be624a747c
November 11, 2022
6
September 05, 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
55413206042314 5000 05413206042319 In Commercial Distribution Carton
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
Yes
No CLOSE

Customer Contact

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