FDA.reportPublic FDA data

Timeter

Primary DI
00260720001620
Brand
Timeter
Company
ALLIED HEALTHCARE PRODUCTS, INC.
Model
15100
Catalog number
T15100
Device description
Assembly, Top, 115 V, CAM 4
Published
2015-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
Single use
false

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
00260720001620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00260720001620002607200016202607200016200260720001620

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099674145
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
40026072025220pc55-01-0014-KZ2023-12-11
40026072025237PC55-01-0014-RU2023-12-11
40026072025244PC55-01-00152023-12-11
40026072025251PC55-01-00162023-12-11
40026072025268PC55-01-00172023-12-11
40026072025275PC55-01-00182023-12-11
40026072025282PC55-01-00192023-12-11
40026072025305PC55-01-00252023-12-11
40026072025312PC55-01-00262023-12-11
40026072025329PC55-01-00272023-12-11
40026072025336PC55-01-00282023-12-11
00260720010523VACUTRON22-18-16082016-08-09
00260720010745Vacutron22-19-16082016-08-26
00260720009374VACUTRONMINI-VAC22-16-16082016-09-12
00260720002627Chemtron219000-2322-10-00022016-09-09
00260720002634Chemtron219000-4322-10-00042016-09-09
00260720002641Chemtron219000-03-RPL22-10-00082016-09-09
00260720011544SchucoS1160-RPLS1160-RPL2016-09-15
00260720011551SchucoS1160A-RPLS1160A-RPL2016-09-15
00260720011568SchucoS1160B-MED2S1160B-MED22016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00026072001622TimeterAllied Medical, LLCBYK2015-11-30
00026072001639TimeterAllied Medical, LLCBYK2015-11-30
00026072001646TimeterAllied Medical, LLCBYK2015-11-30
00260720001637TimeterALLIED HEALTHCARE PRODUCTS, INC.BYK2015-11-30
00260720001644TimeterALLIED HEALTHCARE PRODUCTS, INC.BYK2015-11-30