FDA UDI
In Commercial Distribution
🇺🇸 United States
Child Bib Apron With Attached Collar .25mm, 20" X 20"
DI: 00812045038869
·
Model: 75053NL-22
·
Flow X Ray Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Child Bib Apron With Attached Collar .25mm, 20" X 20"
- Primary DI
- 00812045038869
- Version / Model
- 75053NL-22
- Company Name
- Flow X Ray Corporation
- Labeler DUNS
- 010016319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-20
- Public Version
- 3
- Public Version Date
- 2023-06-28
- Public Version Status
- Update
- Public Device Record Key
- 25f4edab-f249-4faf-8e75-11bcbb17562c
Device Description
Child Bib Apron With Attached Collar, .25mm, 20" X 20" Navy Blue
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IWO | Apron, Protective | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64135 | Patient radiation shielding pad/drape, reusable | A protective device intended to be placed on/draped over part of a patient’s body during a diagnostic or therapeutic radiological procedure to shield specific patient anatomies from unnecessary exposure to radiation and/or help block scatter radiation from the patient to protect healthcare workers.. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material; it is not a piece of clothing such as an apron. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812045038869 | GS1 |