AccessGUDID - DEVICE: Timeter (00026072001622)

GUDID

Device Identifier (DI) Information

Brand Name: Timeter
Version or Model: 15100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T15100
Company Name: Allied Medical, LLC

Primary DI Number: 00026072001622
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119066872 *Terms of Use

Device Description: Assembly, Top, 115 V, CAM 4

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45545	Oxygen administration tent, neonatal/paediatric	A flexible enclosure designed to cover the bed of a neonatal or small child to provide an enriched environment of oxygen (O2) 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, the tubing, and may have built-in humidification. It is used for the treatment of breathing disorders in infant and paediatric patients permitting them movement without restriction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYK	Tent, Oxygen, Electrically Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941547	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6902f7e5-4f5e-4840-8ed5-b0328608649a
Public Version Date: October 13, 2025
Public Version Number: 6
DI Record Publish Date: November 30, 2015

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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