Model: PIP200000
Catalog: PIP200000
DI: 00849884007398
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
20G x 8cm Stiletto Extended Dwell Catheter
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
026234c8-5251-4b96-930b-f57a7e1ea90c
Distribution Status:
In Commercial Distribution
DUNS Number:
120818216
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:
No
Identifiers
Item #1 - Device ID:
30849884007399
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00849884007398
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00849884007398
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
50849884007393
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
20
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
30849884007399
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 64574
Name: Peripheral intravenous cannula
Definition:
A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.
FDA Product Codes
PND
Midline catheter
Premarket Submissions
Submission Number:
K210047
Supplement Number:
000