FDA UDI
In Commercial Distribution
🇺🇸 United States
ProtectX
DI: 20860005250060
·
Model: LTF-0218-25-B
·
The Azac Group
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
10
Basic Information
- Brand Name
- ProtectX
- Primary DI
- 20860005250060
- Version / Model
- LTF-0218-25-B
- Catalog Number
- LTF-0218-25-B
- Company Name
- The Azac Group
- Labeler DUNS
- 067056009
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-04-07
- Public Version
- 1
- Public Version Date
- 2022-04-15
- Public Version Status
- New
- Public Device Record Key
- 6df2cbd4-0b09-4f20-92d2-4309923d0ef6
Device Description
AAMI LEVEL 3 DISPOSABLE PROTECTIVE GOWN OVER THE HEAD WITH THUMB LOOP NONSTERILE EXTRA LARGE BLUE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35492 | Isolation gown, single-use | A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20860005250060 | GS1 | ||||
| Package | 30860005250067 | GS1 | Plastic Bag | 2 | In Commercial Distribution | |
| Package | 40860005250064 | GS1 | Box | 8 | In Commercial Distribution | |
| Package | 50860005250061 | GS1 | Case | 20 | In Commercial Distribution | |
| Unit of Use | 10860005250063 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211538 | 000 |