FDA UDI
In Commercial Distribution
🇺🇸 United States
PATIENT GOWN
DI: 00634916247367
·
Model: 74147090
·
STANDARD TEXTILE CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
48
Basic Information
- Brand Name
- PATIENT GOWN
- Primary DI
- 00634916247367
- Version / Model
- 74147090
- Catalog Number
- 74147090
- Company Name
- STANDARD TEXTILE CO., INC.
- Labeler DUNS
- 006999858
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 48
- Record Status
- Published
- Publish Date
- 2018-01-29
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- afe1b633-5635-4208-a4c4-08bf3a1fd70a
Device Description
PATIENT GOWN 3 ARM HOLE KALIED YELLOW OSFA WRAP AROUND NO TIES SELF BNDG
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
- 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
- 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 |
|---|---|---|---|---|
| FME | Gown, Examination | General Hospital | 880.6265 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11905 | Patient gown, reusable | A garment made of natural and/or synthetic materials (e.g., cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and is closed by ties at the back/side of the garment. This is a reusable garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00634916247367 | GS1 | ||||
| Unit of Use | 10634916247367 | GS1 |
Customer Contacts
- Phone
- 1-800-999-0400
- [email protected]