FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Caleo
DI: 04048675017165
·
Model: 2M50000
·
Drägerwerk AG & Co. KGaA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Caleo
- Primary DI
- 04048675017165
- Version / Model
- 2M50000
- Company Name
- Drägerwerk AG & Co. KGaA
- Labeler DUNS
- 315578914
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 4
- Public Version Date
- 2023-07-25
- Public Version Status
- Update
- Public Device Record Key
- 99c37a3a-d12d-4f1e-8bb4-7312486842ae
- Distribution End Date
- 2017-12-31
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FMZ | Incubator, Neonatal | General Hospital | 880.5400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36025 | Conventional infant incubator | A mains electricity (AC-powered) unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 04048675240341 | GS1 | ||||
| Primary | 04048675017165 | GS1 |
Customer Contacts
- Phone
- +494518820
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003067 | 000 |