DEVICE: Curaplex (00812574024739)

Device Identifier (DI) Information

Curaplex
301-PFR70WE2N
In Commercial Distribution

TRI-ANIM HEALTH SERVICES, INC.
00812574024739
GS1

1
010712461 *Terms of Use
FILTER, PFT, CURAPLEX, 30.1 MM, 34 MM OD, ELIPTICAL MOUTH PIECE, NOSECLIP
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
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?
60506 Pulmonary function testing kit
A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
BZG SPIROMETER, DIAGNOSTIC
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042758 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 30 Millimeter
CLOSE

Device Record Status

3cb85a04-aa77-40bb-b0d7-c8181b07d1a8
July 06, 2018
3
December 14, 2016
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
00812574024746 100 00812574024739 In Commercial Distribution
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE