FDA UDI
In Commercial Distribution
🇺🇸 United States
NAR
DI: 00842209130665
·
Model: 70-0426
·
NORTH AMERICAN RESCUE, LLC
Product Codes
1
GMDN Terms
5
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NAR
- Primary DI
- 00842209130665
- Version / Model
- 70-0426
- Catalog Number
- 70-0426
- Company Name
- NORTH AMERICAN RESCUE, LLC
- Labeler DUNS
- 832426782
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-29
- Public Version
- 2
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- 26b8802f-691c-42cd-b746-427a70d3bb41
Device Description
BLOODBORNE PATHOGEN PPE KIT
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
- 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 |
|---|---|---|---|---|
| PXC | Personal Protection Kit | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15056 | Shoe cover | A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device. | No | Active |
| 35429 | Sharps container | A hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration. | No | Active |
| 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 |
| 66199 | Surgical/medical face mask, non-antimicrobial, single-use | A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device. | No | Active |
| 66899 | Contaminated waste bag | A flexible plastic pouch intended for the safe collection, storage, transportation and disposal of contaminated and/or otherwise hazardous biological materials, typically containing or having been in contact with bodily substances such as blood, sputum, urine, faeces; it is not intended for in vitro diagnostic purposes. It is typically identified with the biohazard symbol on its labelling and may be colour coded. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842209130665 | GS1 |