FDA.reportPublic FDA data

Timeter

Primary DI
00026072001646
Brand
Timeter
Company
Allied Medical, LLC
Model
16394
Catalog number
T16394
Device description
CAM 4, w/ PCS 414, 230 V / 50 Hz
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
00026072001646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072001646000260720016460260720016460026072001646

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
00026072011058Chemtron94-130134-10-00252016-09-15
00026072023723Chemtron3022-G34-10-00052016-09-12
00026072011225B&F643752016-08-24
00026072011232B&F643762016-08-24
00026072011249B&F643772016-08-24
00026072011256B&F643782016-08-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00026072001622TimeterAllied Medical, LLCBYK2015-11-30
00026072001639TimeterAllied 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