FDA UDI
In Commercial Distribution
🇺🇸 United States
Cerulean
DI: 00860004968634
·
Model: NC-352003L
·
J & A Global Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cerulean
- Primary DI
- 00860004968634
- Version / Model
- NC-352003L
- Company Name
- J & A Global Inc.
- Labeler DUNS
- 603660460
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-10
- Public Version
- 1
- Public Version Date
- 2022-11-18
- Public Version Status
- New
- Public Device Record Key
- a2034028-c08c-4579-9f09-1848ee9864e2
Device Description
Powder Free Nitrile Exam Gloves (Blue) Large Case
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60660 | Nitrile examination/treatment glove, non-powdered, antimicrobial | A device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe transmission/exposure and its inner surface is not covered with powder. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860004968634 | GS1 |