Timeter

Primary DI
00026072001639
Brand
Timeter
Company
Allied Medical, LLC
Model
15110
Catalog number
T15110
Device description
Top Assembly, 230 V, CAM 4
Published
2015-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BYKTent, Oxygen, Electrically Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYKTent, Oxygen, Electrically PoweredAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941547000CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENTAllied Healthcare Products, Inc.1995-03-01BYK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00026072001639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072001639000260720016390260720016390026072001639

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration tent, neonatal/paediatricA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119066872
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00026072021439PC11-20-00112024-09-17
00026072026861ALLIED MEDICAL LLC01-90-310001-90-31002025-10-13
00026072026878ALLIED MEDICAL LLC01-90-3100-KIT01-90-3100-KIT2025-10-13
00026072026892ALLIED MEDICAL LLC01-90-392801-90-39282025-10-13
00026072026908ALLIED MEDICAL LLC01-90-3928-KIT 01-90-3928-KIT 2025-10-13
00026072001479EMLPEEP2024-05-28
00026072012161BF645502024-05-28
00026072020548BF64095-AHP2024-10-11
00026072022177EML599-0102024-05-28
00026072022184EML599-0302024-05-28
00026072022191EML599-1302024-05-28
00026072022207EML599-1402024-05-28
00026072022214EML599-1802024-05-28
00026072022238EML599-1902024-05-28
00026072022252EML599-2802024-05-28
00026072022924BF338002024-10-11
00026072022931BF338012024-05-28
00026072023006BF332072024-10-11
00026072023013BF640072024-10-11
00026072023037BF640412024-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00026072001622TimeterAllied Medical, LLCBYK2015-11-30
00026072001646TimeterAllied Medical, LLCBYK2015-11-30
00260720001620TimeterALLIED HEALTHCARE PRODUCTS, INC.BYK2015-11-30
00260720001637TimeterALLIED HEALTHCARE PRODUCTS, INC.BYK2015-11-30
00260720001644TimeterALLIED HEALTHCARE PRODUCTS, INC.BYK2015-11-30