Device
Blood collection needle 20G x 1" (0,9 x 25mm), 100pcs box, for single use.
Manufacturer
CHIRANA T.Injecta, a. s.
CHIRANA T.Injecta, a. s.
Model: 20G x 1"
Catalog: CHBCN20100
DI: 08586015044809
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Blood collection needle 20G x 1" (0,9 x 25mm), 100pcs box, for single use.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
44f2b892-7076-4a51-9702-6fab4586f635
Distribution Status:
In Commercial Distribution
DUNS Number:
495329266
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
carton
Item #1 - Device ID:
48586015044807
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08586015044809
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08586015044809
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 35209
Name: Non-fixed blood collection needle
Definition:
A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.
FDA Product Codes
FMI
Needle, Hypodermic, Single Lumen
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
Premarket Submissions
Submission Number:
K201009
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Gauge
Device Size - Size - @attributes - Value:
20
Device Size - Size Type:
Needle Gauge
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
0
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
40
Storage Handling - Storage Handling Type:
Storage Environment Temperature