| Primary Device ID | 10724995183926 |
| NIH Device Record Key | a0294ed7-f96e-4910-8867-93d32a37e964 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 00711557 |
| Catalog Number | 00711557 |
| Company DUNS | 627879687 |
| Company Name | US Endoscopy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Phone | +1(800)548-4873 |
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| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995183929 [Primary] |
| GS1 | 00816765013564 [Previous] |
| GS1 | 10724995183926 [Package] Contains: 00724995183929 Package: Box [20 Units] In Commercial Distribution |
| NWU | Endoscope introducer kit |
| PRT | Gastric irrigation and aspiration kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-09 |
| Device Publish Date | 2020-04-01 |
| 00724995244545 - Lumiflex | 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm wire is made of nylon and is a progressive stage balloon capable of three |
| 00724995244552 - Lumiflex | 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm wire is made of nylon and is a progressive stage balloon capable of three |
| 00724995244569 - Lumiflex | 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/10mm wire is made of nylon and is a progressive stage balloon capable of thre |
| 00724995244576 - Lumiflex | 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm wire is made of nylon and is a progressive stage balloon capable of thre |
| 00724995244583 - Lumiflex | 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm wire is made of nylon and is a progressive stage balloon capable of thre |
| 00724995244590 - Lumiflex | 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm wire is made of nylon and is a progressive stage balloon capable of thre |
| 00724995244606 - Lumiflex | 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm no wire is made of nylon and is a progressive stage balloon capable of th |
| 00724995244613 - Lumiflex | 2025-06-11 LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm no wire is made of nylon and is a progressive stage balloon capable of th |