DEVICE: Timeter (00260720011766)

Device Identifier (DI) Information

Timeter
T12730
In Commercial Distribution

ALLIED HEALTHCARE PRODUCTS, INC.
00260720011766
GS1

1
099674145 *Terms of Use
Nebulizer
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Oxygen administration tent, adult A flexible enclosure designed for the top of a bed that is used to cover the head/torso of an adult patient to provide an enriched oxygen (O2) environment to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It typically consists of a metal frame covered with transparent plastic, tubing, and may have built-in humidification. It is used for the treatment of breathing and other cardiopulmonary disorders, and for patients who are adverse to oxygen delivery devices such as a nasal cannula, face mask or endotracheal (ET) tube. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CAF Nebulizer (Direct Patient Interface)
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
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

4749ee03-525a-41ec-be48-f4f77663ff5a
March 29, 2018
2
August 30, 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
No Package DIs found
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
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE