Model: FlexGRIP Universal 11-18 Fr
Catalog: UN1118-CAP
DI: 05430000258753
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Sterilized Product- Distributed by Cook
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c571a6da-f612-4fac-94d6-8f7232e5c529
Distribution Status:
In Commercial Distribution
DUNS Number:
370066406
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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 - Pkg Type:
Secondary box
Item #1 - Device ID:
05430000258791
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
50
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05430000258753
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05430000258753
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Tertiary box
Item #3 - Device ID:
05430000258838
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
8
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
05430000258791
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 58301
Name: Synthetic polymer semi-permeable film dressing, adhesive
Definition:
A transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.
FDA Product Codes
KMK
Device, Intravascular Catheter Securement
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
10
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
30
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling Low - @attributes - Value:
50
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling High - @attributes - Value:
86
Item #2 - Storage Handling Type:
Storage Environment Temperature