FDA UDI In Commercial Distribution 🇺🇸 United States

FLEXI-SEAL

DI: 00768455207114 · Model: 422291 · CONVATEC, PURCHASING DEPARTMENT
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
FLEXI-SEAL
Primary DI
00768455207114
Version / Model
422291
Company Name
CONVATEC, PURCHASING DEPARTMENT
Labeler DUNS
809784593
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-14
Public Version
2
Public Version Date
2023-04-21
Public Version Status
Update
Public Device Record Key
8e02bb22-7f9b-4c12-bc80-83ab4925bf1f

Device Description

Flexi-Seal™ Privacy FMS Collection Bags With Filter For Protect Plus Only

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EZQ POUCH, COLOSTOMY

GMDN Terms

Code Name
47038 Faecal incontinence collector, catheterization

Identifiers

Type ID
Package 00768455157174
Primary 00768455207114
Package 10768455157171

Customer Contacts

Phone
+18004228811