O-Two

Primary DI
17540195004501
Brand
O-Two
Company
O-Two Medical Technologies Inc
Model
01BM1000
Catalog number
01BM1000-CS
Device description
The Adult Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate appropriate for adult patients.The LED light on the 01BM1000 is powered by a 3.0V coin battery to provide 10BPM flashing rate (1.5 sec ON, 4.5 sec OFF).
Published
2019-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JBSTimer, General Laboratory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBSTimer, General LaboratoryClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540195004501PackageGS150In Commercial Distribution
07540195004504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754019500450117540195004501
07540195004504075401950045047540195004504

GMDN Terms#

Term, Definition table
TermDefinition
Elapsed-time clock, electronicA battery-powered electronic device designed to measure and indicate length of time (elapsed time) typically in association with various medical, surgical, and laboratory procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight3.6Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-387-3405cs@otwo.com

Regulatory Flags#

DUNS number
206449154
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
07540195015029O-Two 17MP13292023-11-07
07540195015036O-Two 17MP11302023-11-07
07540195020252O Two 01DV2000-FER2024-04-29
07540195020269O Two 01DV2000-FER2024-04-29
17540195040073Pro NoxCMI-0100-PNX 2023-11-13
07540195015012O-Two 08GL1042U2023-11-07
07540195050051O-Two 01FCO115D2023-11-07
07540195050075O-Two 01FCO125D2023-11-07
07540195035157O-Two 01CV02202023-06-22
17540195035154O-Two 01CV02202023-06-22
07540195060111O-TWO 01RO01O10-B2023-06-06
07540195060241O-TWO 01RO01O23-B2023-06-06
07540195086616O-TWO 01RN09N10-B2023-06-06
07540195005174O-Two01CV801501CV8015-CS2019-05-31
07540195005181O-Two01CV801601CV8016-CS2019-05-31
07540195005211O-Two01CV801901CV8019-CS2019-05-31
07540195005334O-Two01CV803001CV8030-CS2019-05-31
07540195005129O-Two01CV801001CV8010-CS2019-05-31
07540195071308O-Two02RT101002RT1010-CS2019-10-31
07540195071322O-Two02RT101202RT1012-CS2019-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840216119437COLLINS SPORTS MEDICINE Asp Global, LLCJBS2022-09-19
07540195004504O-TwoO-Two Medical Technologies IncJBS2019-05-03
07540195004511O-TwoO-Two Medical Technologies IncJBS2019-05-03
17540195004518O-TwoO-Two Medical Technologies IncJBS2019-05-03