FDA UDI
In Commercial Distribution
🇺🇸 United States
Essential Cares
DI: 00850018936385
·
Model: MLCTWTKCCNP-S-ES
·
Essential Cares Supplies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Essential Cares
- Primary DI
- 00850018936385
- Version / Model
- MLCTWTKCCNP-S-ES
- Catalog Number
- MLCTWTKCCNP-S-ES
- Company Name
- Essential Cares Supplies, Inc.
- Labeler DUNS
- 809399350
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-03-30
- Public Version
- 1
- Public Version Date
- 2023-04-07
- Public Version Status
- New
- Public Device Record Key
- 2e0eda5d-cfa2-43b1-b9b3-07c850656a6b
Device Description
Lab Coat SMS White Knit Cuff Knit Collar No Pocket Small Essential Cares 10pc/Bg 3Bg/Cs
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OEA | Non-Surgical Isolation Gown | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32170 | Professional examination gown, single-use | A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10850018936382 | GS1 | ||||
| Primary | 00850018936385 | GS1 | ||||
| Package | 00850018936460 | GS1 | Case | 3 | In Commercial Distribution |
Customer Contacts
- Phone
- 2137431402
- [email protected]