FDA UDI
In Commercial Distribution
🇺🇸 United States
AeroForm® Tissue Expander
DI: 10851452007010
·
Model: 400cc Small
·
AIRXPANDERS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AeroForm® Tissue Expander
- Primary DI
- 10851452007010
- Version / Model
- 400cc Small
- Catalog Number
- BR125-400
- Company Name
- AIRXPANDERS INC
- Labeler DUNS
- 860020127
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-21
- Public Version
- 3
- Public Version Date
- 2019-09-23
- Public Version Status
- Update
- Public Device Record Key
- 0dc8af7a-35f3-4ccf-8f50-5eb5236f7904
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
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PQN | Carbon dioxide gas controlled tissue expander | General, Plastic Surgery | 878.3510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59370 | Remotely-controlled tissue expander | A device intended for implantation to develop tissue (skin) coverage by intermittent expansion, which can be remotely controlled by the patient or physician, prior to the placement of a permanent breast implant. Expansion is achieved by electronic release of gas [e.g., carbon dioxide (CO2)] from a pressurized container within the device. It typically consists of an outer silicone shell, an inner gas barrier, a reservoir of gas with valve, and electronics. It is intended to remain in situ until desired expansion is achieved, when it is replaced with the breast implant. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10851452007010 | GS1 |
Customer Contacts
- Phone
- +1(877)349-2479
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 400 | Milliliter | |
| Device Size Text, specify | Small, 400cc |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius