FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hospitak, Mouth to Mask Resuscitator with Filter Child Mask
DI: 00084424900604
·
Model: 1056-E
·
UNOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Hospitak, Mouth to Mask Resuscitator with Filter Child Mask
- Primary DI
- 00084424900604
- Version / Model
- 1056-E
- Catalog Number
- 1056-E
- Company Name
- UNOMEDICAL, INC.
- Labeler DUNS
- 030271837
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-15
- Public Version
- 3
- Public Version Date
- 2021-04-09
- Public Version Status
- Update
- Public Device Record Key
- 342cda61-0a3c-4e45-baf1-769e0fb16315
- Distribution End Date
- 2021-04-08
Device Description
Hospitak, Mouth to Mask Resuscitator with Filter Child Mask
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
- No
- 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 |
|---|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | Anesthesiology | 868.5915 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57824 | Resuscitator face mask, single-use | A non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00084424900604 | GS1 | ||||
| Package | 20844249006041 | GS1 | case | 20 | Not in Commercial Distribution | 2021-04-08 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K873286 | 000 |