DEVICE: Brava (05708932715720)

Device Identifier (DI) Information

Brava
12036
In Commercial Distribution
12036
Coloplast A/S
05708932715720
GS1

1
305524696 *Terms of Use
Brava Protective Seal. Feel Secure. Ostomy Care. Thickness 2.5 mm, Diameter Inner 18 mm, Diameter Inner 3/4 in, Diameter Outer 57 mm, Diameter Outer 2 1/4 in.
CLOSE

Device Characteristics

MR Safe
No
No
Yes
No
Yes
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46207 Peristomal/periwound dressing
A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EXB COLLECTOR, OSTOMY
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Thickness - mm 2.5
Lumen/Inner Diameter: 18 Millimeter
Device Size Text, specify: Diameter Inner - in 3/4
Outer Diameter: 57 Millimeter
Device Size Text, specify: Diameter Outer - in 2 1/4
CLOSE

Device Record Status

761f1bc0-ef32-460b-be4e-45a78a3e7a27
April 18, 2022
1
April 08, 2022
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
05708932409452 10 05708932715720 In Commercial Distribution Retail Box
05708932409438 50 05708932409452 In Commercial Distribution Shipper Box
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
No
No CLOSE

Customer Contact

[?]
+1(800)533-0464
healthcarecs@coloplast.com
CLOSE