FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 14250105628507
·
Model: 88-11-000
·
VBM Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- n.a.
- Primary DI
- 14250105628507
- Version / Model
- 88-11-000
- Company Name
- VBM Medizintechnik GmbH
- Labeler DUNS
- 324869601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-25
- Public Version
- 2
- Public Version Date
- 2022-09-12
- Public Version Status
- Update
- Public Device Record Key
- 1d0292c1-8343-47ca-835f-7d049dfcd12b
Device Description
Small Infant Mask
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BYW | Device, Rebreathing | Anesthesiology | 868.5675 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35176 | Anaesthesia face mask, reusable | A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24250105628504 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 14250105628507 | GS1 |
Customer Contacts
- Phone
- +49745495960
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | #0; 15 mm O.D. |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -18 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius