FDA UDI
In Commercial Distribution
🇺🇸 United States
O-Two
DI: 07540195004511
·
Model: 01BM1500
·
O-Two Medical Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- O-Two
- Primary DI
- 07540195004511
- Version / Model
- 01BM1500
- Catalog Number
- 01BM1500-CS
- Company Name
- O-Two Medical Technologies Inc
- Labeler DUNS
- 206449154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-03
- Public Version
- 1
- Public Version Date
- 2019-05-13
- Public Version Status
- New
- Public Device Record Key
- f820d74c-e1f4-406a-b67d-52c23a2a3ff5
Device Description
The Child Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate appropriate for child patients. The green LED light on the 01BM1500 is powered by a 3.0V coin battery to provide a 20 BPM flashing rate (1.0 sec ON and 2.0 sec OFF)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JBS | Timer, General Laboratory | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36712 | Elapsed-time clock, electronic | A battery-powered electronic device designed to measure and indicate length of time (elapsed time) typically in association with various medical, surgical, and laboratory procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17540195004518 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 07540195004511 | GS1 |
Customer Contacts
- Phone
- 1-800-387-3405
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 3.6 | Gram | |
| Circumference | 94 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius