FDA UDI
In Commercial Distribution
🇺🇸 United States
CPR Timer
DI: 04942962603669
·
Model: 60366
·
ATOM MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CPR Timer
- Primary DI
- 04942962603669
- Version / Model
- 60366
- Catalog Number
- 60366
- Company Name
- ATOM MEDICAL CORPORATION
- Labeler DUNS
- 690632047
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2019-01-29
- Public Version Status
- Update
- Public Device Record Key
- 48882f4e-8c40-4a80-a589-48b08145ec21
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHB | Timer, Apgar | General Hospital | 880.2930 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35533 | Apgar score timer | A device used during childbirth to measure and indicate a length of time at predetermined intervals from the setting time; this being when the baby is born. The time intervals are typically 1, 5 and 10 minutes. It is used to determine the physical health of a newborn infant and its response to birth and life outside the womb according to a weighed score named after the name of the inventor, Virginia Apgar, who devised the Apgar score, which commonly transpires as: Appearance (colour), Pulse (heartbeat), Grimace (reflex), Activity (muscle tone), and Respiration/breathing (APGAR). The total numerical score is 10. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04942962603669 | GS1 |
Customer Contacts
- Phone
- +81 488533661
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 40 Degrees Celsius