FDA UDI
In Commercial Distribution
🇺🇸 United States
BE 4500 Mask/Filter Storage Box
DI: M996BE45000
·
Model: BE 4500
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BE 4500 Mask/Filter Storage Box
- Primary DI
- M996BE45000
- Version / Model
- BE 4500
- Catalog Number
- BE 4500
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-28
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- 1e08a096-873c-4e88-95cb-4d3fe53fb6aa
Device Description
Wall-mounted storage box provides storage and immediate availability for emergency-use items such as oxygen masks, resuscitator bags, airways, masks, filters, etc. (The storage box does not include these items.) Dimensions: 9-1/4" Length x 6" Width x 4-1/2" Depth.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| BYG | Mask, Oxygen | Anesthesiology | 868.5580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62736 | Medical device storage mount | A permanently-fixed structure upon which a medical device (not included) is designed to be mounted for storage purposes only; the device is not intended to be operated whilst mounted to this device. It is commonly wall-mounted and may be available in a variety of designs (e.g., wall bracket), may be dedicated to a specific type of device, or non-dedicated; it is not a shelf. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M996BE45000 | HIBCC |
Customer Contacts
- Phone
- 4128541133
- [email protected]