Regard™
- Primary DI
- 00326053117466
- Brand
- Regard™
- Company
- Resource Optimization & Innovation, L.L.C.
- Model
- A4ISOGXLNS-REG
- Catalog number
- 382950
- Device description
- GOWN ISOL PULLOVER AAMI4 XL
- Published
- 2020-09-10
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| OEA | Non-Surgical Isolation Gown |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| OEA | Non-Surgical Gown | General, Plastic Surgery | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10326053117463 | Package | GS1 | 60 | Not in Commercial Distribution |
| 00326053117466 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10326053117463 | 10326053117463 | ||
| 00326053117466 | 00326053117466 | 326053117466 | 0326053117466 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Regulatory Flags#
- DUNS number
- 134472476
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 20326053123522 | Regard™ | TLPCHCLR-REG | 2026-03-11 | |
| 20326053123539 | Regard™ | TLPCHSTRP-REG | 2026-03-11 | |
| 10326053103015 | Regard™ | UN 401 | UN 401 | 2023-08-17 |
| 10326053117340 | Regard™ | AN1084 | 2019-09-18 | |
| 10326053118071 | Regard™ | DSPSCRBSHRTL-REG | DSPSCRBSHRTL-REG | 2023-01-11 |
| 10326053118088 | Regard™ | DSPSCRBSHRTM-REG | DSPSCRBSHRTM-REG | 2023-01-11 |
| 10326053118095 | Regard™ | DSPSCRBSHRTXL-REG | DSPSCRBSHRTXL-REG | 2023-01-11 |
| 10326053118101 | Regard™ | DSPSCRBSHRTXXL-REG | DSPSCRBSHRTXXL-REG | 2023-01-11 |
| 10326053118118 | Regard™ | DSPSCRBPNTL-REG | DSPSCRBPNTL-REG | 2023-01-11 |
| 10326053118125 | Regard™ | DSPSCRBPNTM-REG | DSPSCRBPNTM-REG | 2023-01-11 |
| 10326053118132 | Regard™ | DSPSCRBPNTXL-REG | DSPSCRBPNTXL-REG | 2023-01-11 |
| 10326053118149 | Regard™ | DSPSCRBPNTXXL-REG | DSPSCRBPNTXXL-REG | 2023-01-11 |
| 10326053118156 | Regard™ | CHMG38GNSM-REG | CHMG38GNSM-REG | 2023-01-10 |
| 10326053118163 | Regard™ | CHMG38GNSL-REG | CHMG38GNSL-REG | 2023-01-10 |
| 10326053118170 | Regard™ | CHMG38GNSXL-REG | CHMG38GNSXL-REG | 2023-01-10 |
| 10326053118187 | Regard™ | CHMG38GNS2XL-REG | CHMG38GNS2XL-REG | 2023-01-10 |
| 10326053118194 | Regard™ | CHMG53GNSM-REG | CHMG53GNSM-REG | 2023-01-10 |
| 10326053118200 | Regard™ | CHMG53GNSL-REG | CHMG53GNSL-REG | 2023-01-11 |
| 10326053118217 | Regard™ | CHMG53GNSXL-REG | CHMG53GNSXL-REG | 2023-01-11 |
| 10326053118224 | Regard™ | CHMG53GNS2XL-REG | CHMG53GNS2XL-REG | 2023-01-11 |
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| 00199536901469 | Blueline | Transparent Supply Solutions Ltd. | OEA | 2026-05-15 |
| 00199536901476 | Blueline | Transparent Supply Solutions Ltd. | OEA | 2026-05-15 |
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